Trial Outcomes & Findings for Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis (NCT NCT06430671)
NCT ID: NCT06430671
Last Updated: 2026-06-08
Results Overview
Number of treatment-emergent adverse events (TEAEs) during the treatment and safety follow-up period. TEAEs were defined as adverse events with first onset or worsening after the first blood donation for CLS12311 production and were graded according to CTCAE v4.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
From first blood donation for CLS12311 production through Week 48 (end of study)
Results posted on
2026-06-08
Participant Flow
Participants with relapsing-remitting multiple sclerosis were recruited at specialized clinical centers according to the protocol-defined inclusion and exclusion criteria between June 2024 and December 2025. A total of 11 participants underwent blood donation for CLS12311 manufacturing, of whom 9 received at least one treatment cycle.
After enrollment, participants underwent blood donation for CLS12311 manufacturing and were assigned to the low-, medium-, or high-dose groups. Two participants discontinued after blood donation and did not receive treatment.
Participant milestones
| Measure |
CLS12311 Low
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
CLS12311 Low
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Overall Study
Withdrawal before treatment
|
1
|
1
|
0
|
Baseline Characteristics
Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
CLS12311 Low
n=3 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=4 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 7.64 • n=9 Participants
|
41.3 years
STANDARD_DEVIATION 5.56 • n=27 Participants
|
27.8 years
STANDARD_DEVIATION 5.12 • n=267 Participants
|
35.1 years
STANDARD_DEVIATION 8.14 • n=265 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Disease duration
|
12.57 months
STANDARD_DEVIATION 11.392 • n=9 Participants
|
19.80 months
STANDARD_DEVIATION 16.391 • n=27 Participants
|
25.93 months
STANDARD_DEVIATION 45.959 • n=267 Participants
|
20.05 months
STANDARD_DEVIATION 27.764 • n=265 Participants
|
|
EDSS score
|
1.0 points
STANDARD_DEVIATION 1.732 • n=9 Participants
|
1.25 points
STANDARD_DEVIATION 0.866 • n=27 Participants
|
1.25 points
STANDARD_DEVIATION 1.500 • n=267 Participants
|
1.182 points
STANDARD_DEVIATION 1.230 • n=265 Participants
|
PRIMARY outcome
Timeframe: From first blood donation for CLS12311 production through Week 48 (end of study)Population: Safety analysis set including all participants who underwent blood donation for CLS12311 production (N=11).
Number of treatment-emergent adverse events (TEAEs) during the treatment and safety follow-up period. TEAEs were defined as adverse events with first onset or worsening after the first blood donation for CLS12311 production and were graded according to CTCAE v4.0.
Outcome measures
| Measure |
CLS12311 Low
n=3 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=4 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety of CLS12311]
|
5 events
|
28 events
|
16 events
|
SECONDARY outcome
Timeframe: From first blood donation for CLS12311 production through Week 48 (end of study)Population: Safety Analysis Set (SAF) including all participants with blood donation for CLS12311 production (N=11).
Number of treatment-related treatment-emergent adverse events (TEAEs) during the treatment and safety follow-up period. TEAEs were defined as adverse events with first onset or worsening after the first blood donation for CLS12311 production, considered related to study treatment or blood donation, and graded according to CTCAE v4.0.
Outcome measures
| Measure |
CLS12311 Low
n=3 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=4 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Incidence of Treatment-Related TEAEs in Each Dose Group [Safety of CLS12311]
|
0 events
|
13 events
|
4 events
|
SECONDARY outcome
Timeframe: From baseline through Week 48 (end of study)Population: Modified safety analysis set including participants who received at least one treatment cycle (N=9).
Number of patients with a centrally confirmed multiple sclerosis relapse in each dose group during the study period. Relapse was assessed according to protocol criteria as new or worsening neurological symptoms lasting at least 24 hours in the absence of fever or infection and confirmed by central neurological review.
Outcome measures
| Measure |
CLS12311 Low
n=2 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=3 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Number of Patients With Confirmed MS Relapse in Each Dose Group [Safety of CLS12311]
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48 (end of study)Population: Modified safety analysis set including participants who received at least one treatment cycle (N=9).
Change from baseline to Week 48 in the number of contrast-enhancing lesions (CEL) and new or enlarging T2 lesions on brain MRI in each dose group.
Outcome measures
| Measure |
CLS12311 Low
n=2 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=3 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Change in Number of New or Enlarging T2 Lesions on Brain MRI in Each Dose Group [Safety of CLS12311]
|
0.0 new brain lesions
Standard Deviation 0.00
|
1.7 new brain lesions
Standard Deviation 0.58
|
2.8 new brain lesions
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Baseline to Week 48 (end of study)Population: Modified safety analysis set including participants who received at least one treatment cycle (N=9).
Change from baseline to Week 48 in Expanded Disability Status Scale (EDSS) score in each dose group. The EDSS ranges from 0 to 10, with higher scores indicating greater disability. Negative values indicate improvement and positive values indicate worsening disability.
Outcome measures
| Measure |
CLS12311 Low
n=2 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=3 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Change in EDSS Score in Each Dose Group [Safety of CLS12311]
|
-0.50 points
Standard Deviation 0.707
|
0.00 points
Standard Deviation 0.866
|
0.00 points
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline to Week 48 (end of study)Population: Modified safety analysis set including participants who received at least one treatment cycle (N=9).
Percent change from baseline to Week 48 in Timed 25-Foot Walk (T25-FW) performance in each dose group. Negative values indicate improvement (faster walking time).
Outcome measures
| Measure |
CLS12311 Low
n=2 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=3 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Change in T25-FW Performance in Each Dose Group [Safety of CLS12311]
|
-7.95 Percent change
Standard Deviation 4.455
|
2.90 Percent change
Standard Deviation 9.971
|
-4.53 Percent change
Standard Deviation 13.417
|
SECONDARY outcome
Timeframe: Baseline to Week 48 (end of study)Population: Modified safety analysis set including participants who received at least one treatment cycle (N=9).
Percent change from baseline to Week 48 in 9-Hole Peg Test (9-HPT) performance in each dose group. Negative values indicate improvement (shorter completion time).
Outcome measures
| Measure |
CLS12311 Low
n=2 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=3 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Change in 9HPT Performance in Each Dose Group [Safety of CLS12311]
|
-11.35 Percent change
Standard Deviation 7.142
|
0.33 Percent change
Standard Deviation 12.505
|
-6.40 Percent change
Standard Deviation 8.084
|
SECONDARY outcome
Timeframe: Baseline to Week 48 (end of study)Population: Modified safety analysis set including participants who received at least one treatment cycle (N=9).
Change from baseline to Week 48 in Symbol Digit Modalities Test (SDMT) score. The SDMT is a cognitive processing speed test with scores ranging from 0 to approximately 110 points. Higher scores indicate better cognitive performance.
Outcome measures
| Measure |
CLS12311 Low
n=2 Participants
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=3 Participants
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 Participants
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Change in SDMT Performance in Each Dose Group [Safety of CLS12311]
|
16.0 points
Standard Deviation 8.49
|
3.3 points
Standard Deviation 6.51
|
13.0 points
Standard Deviation 7.16
|
Adverse Events
CLS12311 Low
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
CLS12311 Medium
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CLS12311 High
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLS12311 Low
n=3 participants at risk
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=4 participants at risk
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 participants at risk
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
33.3%
1/3 • Number of events 1 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
0.00%
0/4 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
0.00%
0/4 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
Other adverse events
| Measure |
CLS12311 Low
n=3 participants at risk
Low dose CLS12311
CLS12311 low: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 Medium
n=4 participants at risk
Medium dose CLS12311
CLS12311 medium: Peptide-coupled Red Blood Cells (RBCs)
uncoupled RBCs: autologous Red Blood Cells (RBCs)
|
CLS12311 High
n=4 participants at risk
High dose CLS12311
CLS12311 high: Peptide-coupled Red Blood Cells (RBCs)
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/3 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
50.0%
2/4 • Number of events 2 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
25.0%
1/4 • Number of events 1 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
0.00%
0/4 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
25.0%
1/4 • Number of events 1 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
50.0%
2/4 • Number of events 3 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
25.0%
1/4 • Number of events 2 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Number of events 1 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
50.0%
2/4 • Number of events 2 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
0.00%
0/4 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
25.0%
1/4 • Number of events 1 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
25.0%
1/4 • Number of events 1 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
0.00%
0/4 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
25.0%
1/4 • Number of events 2 • From blood donation for CLS12311 through the end of safety follow-up (up to Week 48)
Treatment-emergent adverse events (TEAEs) were defined as adverse events with onset or worsening after the blood donation for CLS12311 production. AEs were collected through the safety follow-up and coded using MedDRA version 27. The adverse event collection period started at blood donation; therefore, the safety analysis set (N=11) includes all participants who donated blood, including those who did not receive a treatment cycle.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place