CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma

Trial Title: CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma

NCT ID: NCT06149169

Condition: Lymphoma, Non-Hodgkin
Diffuse Large B Cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin

Conditions: Keywords:
JWCAR029
B-Cell Malignancies
CAR T cells
Chimeric antigen receptor
Relapsed/Refractory

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: CD19-targeted Chimeric Antigen Receptor(CAR) T Cells
Description: Relma-cel be administered at one dose level:1×10^8 CAR+T cells
Arm group label: Relma-cel

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 the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment. 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(supplement study) 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 include 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 procedur; 9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss 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. Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma; 2. History of another primary malignancyn that has not been in remission for at least 2 years; 3. Subjects has HBV,HCV,HIV or syphilis nefection 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,corticisteriod,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
Zip: 300060
Country: China

Start date: August 17, 2023

Completion date: March 31, 2025

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/NCT06149169