Trial Outcomes & Findings for Pembrolizumab in MarginalzoneLymphoma A MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY (NCT NCT04268277)

Last Updated: 2026-02-27

Results Overview

CR rate (CRR) 4 weeks after end of treatment (18 cycles) according to the GELA (Copie-Bergman C, Gaulard P, Lavergne-Slove A, Brousse N, Flejou JF, Dordonne K, et al. Proposal for a new histological grading system for post-treatment evaluation of gastric MALT lymphoma. Gut 2003 Nov; 52(11): 1656.) criteria for gastric MALT or to the Cheson 2007 (Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007 Feb 10; 25(5): 579-586.) criteria for non-gastric extranodal, nodal and splenic MZL: Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

4 weeks after end of treatment (18 cycles), approx. 58 weeks

Results posted on

2026-02-27

Participant Flow

Study was cancelled when 22 of 56 planned participants had been included

Participant milestones

Participant milestones
Measure	Rituximab & Pembrolizumab Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Treatment Period STARTED	22
Treatment Period COMPLETED	14
Treatment Period NOT COMPLETED	8
Follow Up Period STARTED	22
Follow Up Period COMPLETED	0
Follow Up Period NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab & Pembrolizumab Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Treatment Period Adverse Event	4
Treatment Period Progressive Disease	1
Treatment Period Physician Decision	3
Follow Up Period Death	3
Follow Up Period Lost to Follow-up	1
Follow Up Period Cancellation of Study	18

Baseline Characteristics

Participants were divided into subtype according to the localization of the origin of the lymphoma.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=24 Participants
Age, Categorical >=65 years	9 Participants n=24 Participants
Sex: Female, Male Female	10 Participants n=24 Participants
Sex: Female, Male Male	12 Participants n=24 Participants
Region of Enrollment Germany	22 Participants n=24 Participants
MZL Subtype Splenic marginal zone lymphoma (SMZL)	8 Participants n=24 Participants • Participants were divided into subtype according to the localization of the origin of the lymphoma.
MZL Subtype Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)	7 Participants n=24 Participants • Participants were divided into subtype according to the localization of the origin of the lymphoma.
MZL Subtype Nodal marginal zone lymphoma (NMZL)	7 Participants n=24 Participants • Participants were divided into subtype according to the localization of the origin of the lymphoma.
Race/Ethnicity, Customized Ethnicity · Asian	0 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	21 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	0 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · African	1 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · Other	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: 4 weeks after end of treatment (18 cycles), approx. 58 weeks

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
CR Rate	3 Participants Interval 3.0 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after end of treatment (18 cycles), approx. 58 weeks

The response rates are evaluated 4 weeks after end of treatment (18 cycles) according to the GELA criteria for gastric MALT or to the Cheson 2007 criteria for non-gastric extranodal, nodal and splenic MZL: Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. Partial Response (PR): \>50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transversal diameter. Stable Disease (SD): not meeting CR, PR or PD criteria Progressive Disease (PD): appearance of any new lesion or \>50% increase from nadir of previously involved lesions.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Response Rate Complete Response (CR)	3 Participants
Response Rate Partial Response (PR)	10 Participants
Response Rate Stable Disease (SD)	7 Participants
Response Rate Progressive Disease (PD)	2 Participants

SECONDARY outcome

Timeframe: 2.1 - 33.2 months

Best response is determined in the time interval from the start of induction therapy to end of follow-up according to the GELA criteria for gastric MALT or to the Cheson 2007 criteria for non-gastric extranodal, nodal and splenic MZL: Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. Partial Response (PR): \>50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transversal diameter. Stable Disease (SD): not meeting CR, PR or PD criteria Progressive Disease (PD): appearance of any new lesion or \>50% increase from nadir of previously involved lesions.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Best Response Partial Response (PR)	11 Participants
Best Response Complete Response (CR)	3 Participants
Best Response Stable Disease (SD)	8 Participants

SECONDARY outcome

Timeframe: 2.1 - 33.2 months

Time to best response is defined as the time from the start of induction to best response the patient achieves (CR, PR)

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Time to Best Response	7.6 months Interval 2.3 to 13.5

SECONDARY outcome

Timeframe: 2.1 - 33.2 months

Time to first response is defined as the time from the start of induction to first response (CR, PR)

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Time to First Response	6.9 months Interval 2.3 to 13.5

SECONDARY outcome

Timeframe: 12 months

Progression free survival (PFS) is defined as the probability for not showing disease progression as assessed by the investigator, or death from any cause within 12 months from registration. PFS for patients without disease progression, relapse, or death was censored at the time of the last tumor assessment if patients were observed for less than 12 months.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Progression Free Survival (PFS)	0.941 probability Interval 0.65 to 0.992

SECONDARY outcome

Timeframe: 2.1 - 33.2 months

Time to treatment failure is defined as the time of registration to discontinuation of therapy for any reason including death from any cause, progression, toxicity or add-on of new anti-cancer therapy. Patients alive without treatment failure are censored at the latest tumor assessment date.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Time to Treatment Failure (TTF)	18.5 months Interval 11.6 to 25.1

SECONDARY outcome

Timeframe: 6 months

The probability that the response takes 6 month will be calculated. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Duration of Response (DR)	0.917 probability Interval 0.539 to 0.988

SECONDARY outcome

Timeframe: 2.1 - 33.2 months

Cause specific survival is the number of subjects who have not died due to lymphoma until the end of study.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Cause Specific Survival (CSS)	22 Participants

SECONDARY outcome

Timeframe: 2.1 - 33.2 months

Overall survival is the number of patients who have not died until the end of study.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Overall Survival (OS)	19 Participants

SECONDARY outcome

Timeframe: End of treatment (4 weeks after cycle 18, approx. 58 weeks)

Quality of life will be measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire, before start of treatment and during trial participation. The FACT-Lym total score combines the subscales for physical, social/family, emotional and functional well-being with a lymphoma subscale representing lymphoma symptoms. The sum of those subscale scores are the total score, which ranged from 0 to 168 whereby higher values represent a better quality of life.

Outcome measures

Outcome measures
Measure	Rituximab & Pembrolizumab n=22 Participants Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Quality of Life During Trial Cycle 1	130.0 Scores on scale Interval 85.0 to 164.8
Quality of Life During Trial Cycle 4	138.9 Scores on scale Interval 70.0 to 164.0
Quality of Life During Trial Cycle 7	138.9 Scores on scale Interval 108.8 to 164.0
Quality of Life During Trial Cycle 10	124.7 Scores on scale Interval 92.7 to 165.0
Quality of Life During Trial Cycle 13	124.2 Scores on scale Interval 95.0 to 167.0
Quality of Life During Trial Cycle 16	144.0 Scores on scale Interval 78.5 to 166.0
Quality of Life During Trial End of treatment (4 weeks after cycle 18, approx. 58 weeks)	125.0 Scores on scale Interval 88.0 to 166.0

Adverse Events

Rituximab & Pembrolizumab

Serious events: 12 serious events

Other events: 21 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab & Pembrolizumab n=22 participants at risk Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Blood and lymphatic system disorders Anaemia	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Cardiac disorders Cardiac Failure	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Cardiac disorders Atrial Flutter	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Endocrine disorders Hypopituitarism	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Diarrhoea	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Gastrointestinal disorder	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Enteritis	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Gastrointestinal inflammation	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Immune-mediated enterocolitis	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
General disorders Pyrexia	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
General disorders Oedema	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
General disorders Polyserositis	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Hepatobiliary disorders Hepatic function abnormal	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Immune system disorders Hypersensitivity	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations COVID-19	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations Pneumonia	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations Infection	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations Febrile Infection	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations Gastroenteritis	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Metabolism and nutrition disorders Tumour lysis syndrome	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Metabolism and nutrition disorders Hyponatraemia	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Metabolism and nutrition disorders Ketoacidosis	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Metabolism and nutrition disorders Spinal stenosis	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Nervous system disorders Central nervous system lesion	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Skin and subcutaneous tissue disorders Rash	4.5% 1/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).

Other adverse events

Other adverse events
Measure	Rituximab & Pembrolizumab n=22 participants at risk Cycle 1 (21 days cycle): Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2 Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity: Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1
Blood and lymphatic system disorders Neutropenia	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Endocrine disorders Hypothyroidism	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Diarrhoea	31.8% 7/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Constipation	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Gastrointestinal disorders Nausea	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
General disorders Fatigue	18.2% 4/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
General disorders Oedema peripheral	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
General disorders Chills	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations COVID-19	18.2% 4/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations Influenza	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations Urinary tract infection	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Infections and infestations Bronchitis	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Injury, poisoning and procedural complications Infusion related reaction	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Metabolism and nutrition disorders Hypokalaemia	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Metabolism and nutrition disorders Vitamin B12 deficiency	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Nervous system disorders Headache	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Psychiatric disorders Sleep disorder	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Renal and urinary disorders Proteinuria	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Respiratory, thoracic and mediastinal disorders Cough	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Skin and subcutaneous tissue disorders Rash	22.7% 5/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Skin and subcutaneous tissue disorders Eczema	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Skin and subcutaneous tissue disorders Pruritus	9.1% 2/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).
Vascular disorders Hypertension	13.6% 3/22 • Adverse events were monitored from the time the patient signed informed consent up to 110 days after the last study drug administration (up to approximately 71 weeks), all-cause mortality was monitored until the end of study (up to 33.2 months).

Additional Information

Coordinating Investigator

Universitätsklinikum Ulm

Phone: +49 731 500 65801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PIs may publish results only after written consent of the Sponsor and the Coordinating Investigator ("Leiter der klinischen Prüfung" acc. to German law). The Sponsor can require changes.
Publication restrictions are in place

Restriction type: OTHER