CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma

Phase 2Active Not RecruitingNCT04718883

Shanghai Ming Ju Biotechnology Co., Ltd.59 enrolled

Overview

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

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment. R/R MCL patients will be enrolled in dose level of 1.0 x 10\^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mantle Cell Lymphoma

Interventions

CD19-targeted Chimeric Antigen Receptor (CAR) T CellsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 18 years old; * Sign on the informed consent; * Subject must have histologically confirmed mantle cell lymphoma; * Relapsed/refractory patients; * 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; * Expected survival is greater than 12 weeks; * 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. Exclusion Criteria: * Central nervous system (CNS) only involvement by malignancy or 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, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * Received allo-hematopoietic stem cell transplantation therapy previously. * 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.

Locations (12)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Consonancy Hospital

Fuzhou, Fujiang, China

Outcomes

Primary Outcomes

Objective response rate (ORR)

Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

Time frame: 3 months

Secondary Outcomes

Complete response rate (CRR)

Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

Time frame: 3 months

The best objective response rate

The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

Time frame: 3 months

The best complete response rate

The best complete response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

Time frame: 3 months

Number of participants with adverse events (AEs)

Number of participants with adverse events

Time frame: Up to 24 months after JWCAR029 infusion

Type of adverse events (AEs)

Type of adverse events

Time frame: Up to 24 months after JWCAR029 infusion

Severity of adverse events(AEs)

Severity of adverse events

Time frame: Up to 24 months after JWCAR029 infusion

Number of participants with laboratory abnormalities

Data from ClinicalTrials.gov

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