Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL
Megadott ok: Due to the COVID-19 pandemic，no subjects enrolled
A legfontosabb adatok
- Fázis
- 1. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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A vizsgálat adatai
- Ki végzi
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Azonosító
- NCT05259813
- A regiszteradat frissítve
- 2023. november 24.
- Eredeti leírás
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 LymphomaA teljes eredeti leírásKevesebb
An Open Label, Single-arm, Phase I Study of JWCAR029 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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 Lymphoma
Bevonási feltételek: ≥ 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.
Kizáró feltételek: Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; 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; Received CAR T-cell or other genetically-modified T-cell therapy previously; 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; 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; Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; Pregnant or nursing women.