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

NCT ID: NCT04812691

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-10
• Study Completion Date: 2023-04-25

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

Detailed Description

This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment.

One dose level of 1.0 x 10^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after JWCAR029 infusion.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

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

Study Groups

JWCAR029

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

Group Type: EXPERIMENTAL

JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)

Intervention Type: 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.

Interventions

JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years old;

2. Sign on the informed consent;

3. Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy;

4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

6. Adequate organ function;

7. Adequate vascular access for leukapheresis procedure;

8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;

9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;

10. 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

Exclusion Criteria

1. Subjects who have received second-line treatment or above

2. CD19 negative

3. Primary CNS lymphoma;

4. History of another primary malignancy that has not been in remission for at least 2 years;

5. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;

6. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;

7. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;

8. Presence of acute or chronic graft-versus-host disease (GVHD);

9. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;

10. Pregnant or nursing women;

11. 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;

12. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;

13. 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

Weili Zhao

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin hospital

Shanghai, Shanghai Municipality, China

Zhejiang university school of medicine first affiliated hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

JWCAR029-003

Identifier Type: -

Identifier Source: org_study_id