Status:
ACTIVE_NOT_RECRUITING
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
Lead Sponsor:
Shanghai Ming Ju Biotechnology Co., Ltd.
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed 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, pharm...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2028
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04718883
Start Date
January 13 2021
End Date
August 7 2028
Last Update
November 24 2023
Active Locations (12)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100000
2
Peking University Third Hospital
Beijing, Beijing Municipality, China
3
Fujian Medical University Consonancy Hospital
Fuzhou, Fujiang, China
4
Guangdong Province people hospital
Guanzhou, Guangdong, China