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

NCT06149169 | Active Not Recruiting Phase 2

• 1 other identifier: JWCAR029-017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, Non-Hodgkin; Diffuse Large B Cell Lymphoma

Keywords

JWCAR029; B-Cell Malignancies; CAR T cells; Chimeric antigen receptor; Relapsed/Refractory

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic(PK)-Cmax of Relma-cel

  Maximum observed concentration of Relma-cel in peripheral blood

  up to 1 year after Relma-cel infusion

• Pharmacokinetic(PK)-Tmax of Relma-cel

  Time to maximum concentration of Relma-cel in peripheral blood

  up to 1 year after Relma-cel infusion

• Pharmacokinetic(PK)-AUC of Relma-cel

  Area under the concentration vs time curve of Relma-cel

  up to 1 year after Relma-cel infusion

Secondary Outcomes (10)

• Objective response rate (ORR) in LBCL subjects

  3 months

• Best objective response rate ( Best ORR) in LBCL subjects

  up to 1 year after Relma-cel infusion

• Complete response rate (CRR) in LBCL subjects

  up to 1 year after Relma-cel infusion

• Adverse events (AEs)

  up to 1 year after Relma-cel infusion

• Duration of response (DOR)

  up to 1 year after Relma-cel infusion

Study Arms (1)

Relma-cel

EXPERIMENTAL

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

Biological: CD19-targeted Chimeric Antigen Receptor(CAR) T Cells

Interventions

CD19-targeted Chimeric Antigen Receptor(CAR) T Cells BIOLOGICAL

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

Relma-cel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old;
• Sign on the informed consent;
• Subjects must have histologically confirmed Large B-cell Lymphoma;
• 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);
• Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
• Adequate organ function;
• Adequate vascular access for leukapheresis procedur;
• Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss CD19;
• Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
• 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.

You may not qualify if:

• Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;
• History of another primary malignancyn that has not been in remission for at least 2 years;
• Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;
• Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
• Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
• Presence of acute or chronic graft-versus-host disease(GVHD);
• History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
• Pregnant or nursing woman;
• 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;
• Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
• Received CAR T-cell or other genetically-modified T-cell therapy previously.

Sponsors & Collaborators

• Shanghai Ming Ju Biotechnology Co., Ltd.: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huilai Zhang

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 28, 2023
• Study Start: August 17, 2023
• Primary Completion: October 30, 2024
• Study Completion: March 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)