Study on the Safety and Effectiveness of JCAR017 for Treating Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) That Has Returned or Not Responded to Treatment

Sponsor: Juno Therapeutics, a Subsidiary of Celgene

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03331198

Provider View

This clinical trial is testing a new treatment called JCAR017 to see if it is safe and effective for adults with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that has come back or not responded to previous treatments. The study will also explore combining JCAR017 with other medications like ibrutinib or venetoclax.

Patient Parameters

Program Overview

The study is divided into two parts. In the first part, researchers will determine the best dose of JCAR017 for treating CLL or SLL that has returned or not responded to treatment. In the second part, they will further assess how well this dose works and how safe it is. Some participants will receive JCAR017 alone, while others will receive it in combination with ibrutinib or venetoclax. The study will take place at multiple centers and will monitor the safety, effectiveness, and how the body processes JCAR017.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CLL or SLL that requires treatment and can be measured by doctors.
  • Must have tried and not responded to certain previous treatments, or be ineligible for them.
  • For those receiving JCAR017 alone, must have failed at least 2 or 3 previous treatments, depending on risk factors.
  • For those receiving JCAR017 with ibrutinib, must be currently taking ibrutinib and not fully responding, or have specific genetic mutations.
  • For those receiving JCAR017 with venetoclax, must have failed at least one previous treatment and not have contraindications to restarting venetoclax.
  • Must be in good overall health with adequate organ function and a performance status score of 0 or 1.
  • Must have central or peripheral vascular access for a procedure called leukapheresis.
  • If previously treated with CD19-targeted therapy, must have CD19-positive disease confirmed.
  • Must agree to follow study procedures and provide informed consent.

Exclusion Criteria

  • Active cancer involvement in the central nervous system (CNS).
  • History of another cancer that has not been in remission for at least 2 years, with some exceptions.
  • History of Richter's transformation.
  • Previous treatment with gene therapy products.
  • Active infections like hepatitis B, hepatitis C, or HIV.
  • Uncontrolled infections or graft versus host disease (GVHD).
  • Recent history of severe heart conditions or significant CNS disorders.
  • Pregnant or breastfeeding women.
  • Recent use of certain medications or treatments before a procedure called leukapheresis.
  • Uncontrolled medical or psychological conditions that prevent following the study protocol.
  • Recent history of blood clots not managed with stable anticoagulation therapy.
  • For those in the venetoclax + JCAR017 group, cannot take certain medications that affect venetoclax.

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