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

NCT ID: NCT06149169

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2025-03-31

Brief 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.

Conditions

Lymphoma, Non-Hodgkin; Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relma-cel

The PK, safety and efficacy of Relma-cel will be evaluated in 1 x 10\^8 CAR+T cells dose level

Group Type: EXPERIMENTAL

CD19-targeted Chimeric Antigen Receptor(CAR) T Cells

Intervention Type: BIOLOGICAL

Relma-cel be administered at one dose level:1×10\^8 CAR+T cells

Interventions

CD19-targeted Chimeric Antigen Receptor(CAR) T Cells

Relma-cel be administered at one dose level:1×10\^8 CAR+T cells

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ming Ju Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huilai Zhang

Role: PRINCIPAL_INVESTIGATOR

Tianjin Cancer Hospital

Locations

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

JWCAR029-017

Identifier Type: -

Identifier Source: org_study_id