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Trial Title:
Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
NCT ID:
NCT05806580
Condition:
Relapsed or Refractory B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Relma-cel
Description:
Patients who have undergone at least one disease assessment after initial Relma-cel
treatment and have not achieved complete remission may receive a second treatment based
on clinical practice. The specific dosage will be determined by the investigator
according to the patient's condition and available dose reserves.
Arm group label:
Relma-cel secondary infusion
Other name:
JWCAR029
Summary:
To observe the efficacy and safety of a second infusion of relma-cel injection in
patients with relapsed or refractory B-cell lymphoma.
Detailed description:
This study aims to collect efficacy and safety data from adult patients with relapsed or
refractory large B-cell lymphoma (r/r LBCL) who receive a second infusion of relma-cel
injection after initial treatment with relma-cel. The study will not include any form of
grouping, and subgroup analysis will be conducted based on the actual data collected.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients have signed an Informed Consent Form (ICF).
- Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed
initial treatment with Relma-cel.
- Patients must have undergone at least one disease assessment post-initial Relma-cel
treatment, and the investigator decides to administer a second treatment (including
PR/PD/SD) based on clinical practice.
- Before the second infusion, confirm that the prepared dose of relma-cel is
sufficient (recommended 80-150 x 10^6 CAR-T cells), with specific dosage determined
by the investigator based on patient condition and dose availability.
- Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.
- Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the
second treatment.
- Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide),
except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels
before retreatment.
- Patients must not have experienced severe adverse reactions during the first
treatment, or any adverse reactions must have resolved to baseline levels from the
first treatment.
Exclusion Criteria:
- Patients with hypersensitivity to active ingredients or any excipients (e.g.,
dimethyl sulfoxide, compound electrolyte injection, human albumin).
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infections
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NO.197， Ruijin Er Road
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao, doctorate
Phone:
+86 021-64370045
Email:
zwl_trial@163.com
Start date:
May 1, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806580
