CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma

Shanghai Ming Ju Biotechnology Co., Ltd.82 enrolled

Overview

This is a phase II, open-label, single-arm, multicenter study to asess the efficacy and safety of JWCAR029 in adult R/R Non-Hodgkins Lymphoma subjects in China.

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with R/R Non-Hodgkins Lymphoma in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect the patient reported quality of life changes and immune response after JWCAR029 treatment. There will be two cohorts of cohort A and cohort B. Large B cell lymphoma (LBCL) patients will be enrolled in cohort A and follicular lymphoma patients will be enrolled in cohort B. Two dose levels of 1.0 x 10\^8 CAR+ T cells and 1.5 x 10\^8 CAR+ T cells are adopted in this study in both cohorts, subjects will be randomly assigned into the two dose levels with a 1:1 ratio. All sujects will be followed for 2 years following JWCAR029 infusion.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Non-Hodgkin Diffuse Large B Cell Lymphoma Follicular Lymphoma

Interventions

CD19-targeted Chimeric Antigen Receptor (CAR) T CellsBIOLOGICAL

JWCAR029 be administered at dose level: 1 x 10\^8 CAR+T cells and 1.5 x 10\^8 CAR+T cells

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must meet all of the following criteria to participate in the study: 1. ≥ 18 years old; 2. Sign on the informed consent; 3. Subject must have histologically confirmed large B lymphoma or follicular lymphoma; 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. Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma; 2. History of another primary malignancy that has not been in remission for at least 2 years; 3. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; 4. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or 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 women; 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.

Locations (10)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Objective response rate (ORR) in LBCL subjects in cohort A;

Objective response rate (ORR) in 3 month in cohort A of large B cell lymphoma (LBCL) subjects；

Time frame: 3 months

Complete response rate (CRR) in FL subjects in cohort B

Complete response rate (CRR) in 3 month in cohort B of follicular lymphoma (FL) subjects

Time frame: 3 months

Secondary Outcomes

Complete response rate (CRR) in cohort A of LBCL subjects

Time frame: 3 months

Objective response rate (ORR) in cohort B of FL subjects

Time frame: 3 months

Adverse events (AEs)

Number of participants with adverse events, type of adverse events, severity of adverse events, and number of participants with laboratory abnormalities, type of laboratory abnormalities and severity of laboratory abnormalities.

Time frame: up to 24 months after JWCAR029 infusion

Duration of response (DOR)

Time from first response(PR or CR) to disease progression or death from any cause.

Time frame: up to 24 months after JWCAR029 infusion

Duration of complete remission (DoCR)

Time from complete response (CR) to disease progression or death from any cause.

Time frame: up to 24 months after JWCAR029 infusion

Duration of partial remission (DoPR)

Time from partial response (PR) to disease progression or death from any cause.

Data from ClinicalTrials.gov

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