CAR T-Cell Therapy for Chronic Lymphocytic Leukemia

Phase 1 & 2

Recruiting

Led By Jennifer N Brudno, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new treatment called anti-CD19 CAR T cell therapy for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Who is the study for?

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that hasn't responded to standard treatments. Participants must have a tumor sample available for CD19 testing, and their heart and overall health should be stable enough to undergo the procedures involved in the trial.

What is being tested?

The study tests anti-CD19 CAR T cell therapy, where patients' own immune cells are modified to target cancer cells. It involves taking medication to reduce leukemia cells, extracting T cells from blood, genetically modifying them in a lab, and then infusing them back into the patient's bloodstream.

What are the potential side effects?

Possible side effects include reactions related to infusion of modified T-cells such as fever, fatigue, headache; complications due to gene editing like abnormal immune responses; and effects from preparatory drugs including nausea and hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL.

Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL

Secondary study objectives

Phase I+II: Assess complete response rate

Phase I+II: Assess duration of responses

Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients

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