CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma

NCT04812691 | Completed Phase 1

• 1 other identifier: JWCAR029-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Primary refractory

Outcome Measures

Primary Outcomes (1)

• Types, frequency, and severity of adverse events and laboratory anomalies

  Physiological parameter

  2 years

Secondary Outcomes (20)

• Complete response rate (CRR) in primary refractory DLBCL subjects

  1 month

• Objective response rate (ORR) in primary refractory DLBCL subjects

  1 month

• Best objective response rate (BORR)

  2 years

• Investigator evaluated CRR

  3 months

• Investigator evaluated ORR (ORR=CR+PR)

  3 months

Study Arms (1)

JWCAR029

EXPERIMENTAL

The safety and efficacy of JWCAR029 will be evaluated in 1 x 10\^8 CAR+T cells dose level

Biological: JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)

Interventions

JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells) BIOLOGICAL

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive 1 x 10\^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.

JWCAR029

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;
• Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy;
• 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 procedure;
• Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
• Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
• Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029

You may not qualify if:

• Subjects who have received second-line treatment or above
• CD19 negative
• Primary CNS lymphoma;
• History of another primary malignancy that has not been in remission for at least 2 years;
• Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
• Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or 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 women;
• 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 (2)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Zhejiang university school of medicine first affiliated hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

relmacabtagene autoleucel

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Weili Zhao

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: March 24, 2021
• Study Start: July 10, 2020
• Primary Completion: June 30, 2021
• Study Completion: April 25, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)