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Trial Title:
CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
NCT ID:
NCT06479356
Condition:
Non-Hodgkin Lymphoma
Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
JWCAR029
B-Cell Malignancies
CAR T cells
Chimeric antigen receptor
Relapsed/Refractory
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Relma-cel
Description:
Relma-cel will be administered at one dose level:1×10^8 CAR+T cells
Arm group label:
Relma-cel
Other name:
CD19-targeted Chimeric Antigen Receptor(CAR) T Cells
Summary:
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma
subjects with Relmacabtagene autoleucel (relma-cel) in China.
Detailed description:
This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in
China to evaluate efficacy，safety and pharmacokinetics(PK) of relma-cel.
Relma-cel was approved by the China National Medical Products Administration(NMPA)in
September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R
LBCL after second-line or more systemic therapy.The recommended dose is 1×10^8 CAR+T
cells.The indication for this application is R/R LBCL and the recommended dose is 1×10^8
CAR+T cells.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥18 years old;
2. Sign on the informed consent;
3. Subjects must have histologically confirmed Large B-cell Lymphoma;
4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted
antibodies) and had relapsed, failed to respond, or progressed after at least two
lines of therapy including autologous hematopoietic stem cell
transplantation(auto-HSCT);
5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion
according to Lugano Classification;
6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
7. Adequate organ function;
8. Adequate vascular access for leukapheresis procedure;
9. Subjects who have previously received CD19 targeted therapy must confirm that
lymphoma lesions still express CD19;
10. Women of childbearing potential must agree to use highly effective methods of
contraception for 1 year after the last dose of Relma-cel;
11. Males who have partners of childbearing potential must agree to use an effective
barrier contraceptive method for 1 year after the last dose of Relma-cel.
Exclusion Criteria:
1. Primary CNS lymphoma;
2. History of another primary malignancy that has not been in remission for at least 2
years;
3. Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires
anti-coagulation within 3 months prior to signing the ICF;
5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
6. Presence of acute or chronic graft-versus-host disease(GVHD);
7. History of any serious cardiovascular disease or presence of clinically relevant CNS
pathology;
8. Pregnant or nursing woman;
9. Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD
therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a
specific wash-out period before leukapheresis;
10. Uncontrolled conditions or unwillingness or inability to follow the procedures
required in the protocol;
11. Received CAR T-cell or other genetically-modified T-cell therapy previously.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Huilai Zhang
Email:
zhlwgq@126.com
Start date:
August 15, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Ming Ju Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Ming Ju Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06479356
