Status:
WITHDRAWN
Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL
Lead Sponsor:
Shanghai Ming Ju Biotechnology Co., Ltd.
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label, single-arm, single center study to assess the safety and efficacy of JWCAR029 in subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic L...
Detailed Description
Upon the successful product generation of Relmacabtagene Autoleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by Relmacabtagen...
Eligibility Criteria
Inclusion
- ≥ 18 years old and ≤ 75 years old;
- Sign on the informed consent;
- Diagnosis of:
- CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or
- SLL (lymphadenopathy and/or splenomegaly and \< 5×10\^9 CD19+ CD5+ clonal B lymphocytes/L \[\< 5000/µL\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL);
- Relapsed/refractory patients, Subjects must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy;
- 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;
- 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 :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05259813
Start Date
February 28 2022
End Date
March 31 2025
Last Update
November 24 2023
Active Locations (1)
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1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029