Status:
UNKNOWN
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma
Lead Sponsor:
Shanghai Ming Ju Biotechnology Co., Ltd.
Conditions:
Lymphoma, Non-Hodgkin
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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), pharmacodynami...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following criteria to participate in the study:
- ≥ 18 years old;
- Sign on the informed consent;
- Subject must have histologically confirmed large B lymphoma or follicular lymphoma;
- 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;
- 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, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- 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 :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04089215
Start Date
June 11 2019
End Date
September 30 2024
Last Update
November 24 2023
Active Locations (10)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
2
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
Beijing Hospital
Beijing, Beijing Municipality, China
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China