Trial Outcomes & Findings for CAR-T Cell Immunotherapy for Advanced Lung Cancer (NCT NCT03330834)

Last Updated: 2020-07-13

Results Overview

Assessed by the treatment-emergent adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram. Treatment-emergent adverse events will be assessed and recorded according to CTCae v4.02. No statistical analysis was performed becuase the study was terminated after only 1 patient received treatment.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

From the date of CAR-T cell infusion through study completion, average 2 years

Results posted on

2020-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CAR-T Cell Immunotherapy for Advanced Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=1 Participants CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells.
Age, Customized age	61 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment China	1 participants n=99 Participants
Tumor Stage	1 Participants n=99 Participants
EGFR mutation status	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: From the date of CAR-T cell infusion through study completion, average 2 years

Outcome measures

Outcome measures
Measure	Treatment Arm n=1 Participants CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells.
Number of Participants With Treatment-Emergent Adverse Events Associated With PD-L1 CAR-T Cell Treatment	1 Participants

SECONDARY outcome

Timeframe: Every three month through study completion, average 2 years

Tumor response will be assessed according to RECIST V1.1. The overall response rate calculated by the numbers of PR or CR / all patients received treatment. The disease control rate calculated by the numbers of CR PR and stable disease / all patients received treatment.

Outcome measures

Outcome measures
Measure	Treatment Arm n=1 Participants CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells.
Number of Participants Experiencing a Complete (CR) or Partial (PR) Tumor Response	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7 after CAR-T cell infusion, and every 2 months up to 2 years

Population: Only 1 patients received treatment and accepted the surveillance of PD-L1 CAR-T cells, and only one detection was performed at Day 7 time point

Using flow cytometry to count of PD-L1 CAR-T cells, calculated the CAR-T cells existence by time after the infusion.

Outcome measures

Outcome measures
Measure	Treatment Arm n=1 Participants CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells.
Numbers of Patients Received Surveillance of PD-L1 CAR-T Cells in Vivo	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, day 7 and 30 after the CAR-T cell infusion

Exploring the correlation of the immune functions of pre- and post-CAR-T cell treatments with the treatment safety and efficacy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, day 7 and 30 after the CAR-T cell infusion

Exploring the correlation of the immune functions of pre- and post-CAR-T cell treatments with the treatment safety and efficacy.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Arm

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm n=1 participants at risk CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells.
Respiratory, thoracic and mediastinal disorders interstitial pneumonia disease	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.

Other adverse events

Other adverse events
Measure	Treatment Arm n=1 participants at risk CAR-T cells to treat advanced lung cancer. This study has only one arm. All participators will attend the screening and meet the set criteria for the clinical treatment. PD-L1 CAR-T cells are infused on day 0 with 10%, day 3 with 30% and day 7 with 60% , (1-2)×10\^6/kg PD-L1 CAR-T cells total. CAR-T cells to treat advanced lung cancer: Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days. Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells.
Respiratory, thoracic and mediastinal disorders Serious Cytokine Release Syndrome causes interstitial pneumonia disease.	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Renal and urinary disorders Uric acid elevation	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
General disorders C-Reactive Protein	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Renal and urinary disorders proteinuria	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Blood and lymphatic system disorders White blood cell counts increasing	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Blood and lymphatic system disorders neutrophilic granulocytosis	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Respiratory, thoracic and mediastinal disorders hemoptysis	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Respiratory, thoracic and mediastinal disorders Chest pain	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Skin and subcutaneous tissue disorders toothache	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Blood and lymphatic system disorders anemia	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
General disorders Albumin decline	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Eye disorders swelling of eye	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.
Blood and lymphatic system disorders thrombocytosis	100.0% 1/1 • Number of events 1 • 24 months Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related. Febrile without any courses and respiratory distress that deteriorated quickly into failure in 3 days.He was immediately transferred to the ICU where he received oxygen via nasal cannula and given intravenous infusions of tocilizumab and large doses of methylprednisolone. His symptoms were quickly improved and the pulmonary inflammation became dissipated gradually.

Additional Information

Dr.Yuxiang Ma

Sun Yat-sen University Cancer Center

Phone: 86 020 87343894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place