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

Last updated: August 19, 2024
Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

CD19-targeted Chimeric Antigen Receptor(CAR) T Cells

Clinical Study ID

NCT06149169
JWCAR029-017
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-targetedantibodies) and had relapsed, failed to respond, or progressed after at least twolines of therapy include autologous hematopoietic stem celltransplantation(auto-HSCT);

  5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesionaccording 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 thatlymphoma lesions still expresss CD19;

  10. Women of childbearing potential must agree to use highly effective methods ofcontraception for 1 year after the last dose of Relma-cel;

  11. Males who have partners of childbearing potential must agree to use an effectivebarrier contraceptive method for 1 year after the last dose of Relma-cel.

Exclusion

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 2years;

  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 requiresanti-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 CNSpathology;

  8. Pregnant or nursing woman;

  9. Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHDtherapies,radiation,allo-HSCT or any other therapies for lymphoma must go through aspecific wash-out period before leukapheresis;

  10. Uncontrolled conditions or unwillingness or inability to follow the proceduresrequired in the protocol;

  11. Received CAR T-cell or other genetically-modified T-cell therapy previously.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: CD19-targeted Chimeric Antigen Receptor(CAR) T Cells
Phase: 2
Study Start date:
August 17, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Tianjin Cancer Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

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