Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL

• ≥ 18 years old and ≤ 75 years old;
• Sign on the informed consent;

• Diagnosis of:

  1. CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or
  2. 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 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.