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

Shanghai Ming Ju Biotechnology

Status and phase

Active, not recruiting

Phase 2

Conditions

Mantle Cell Lymphoma

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04718883

JWCAR029-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.