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CAR T-cell Therapy

Genetically Modified T Cells for Chronic Lymphocytic Leukemia

Phase 1 & 2

Waitlist Available

Led By Jae Park, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Must have adequate cardiac function (LVEF ≥40%) as assessed by ECHO or MUGA scan within 1 month of treatment

Patients must have CD19+ B cell leukemia or lymphoma with relapsed or chemotherapy-refractory disease or evidence of residual disease following therapy confirmed at MSKCC

Must not have

Patients with specific cardiac conditions: New York Heart Association (NYHA) stage III or IV congestive heart failure, myocardial infarction ≤6 months prior to enrollment, history of clinically significant ventricular arrhythmia or unexplained syncope, history of severe non-ischemic cardiomyopathy with EF ≤20%

Patients with HIV, hepatitis B, or hepatitis C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using a patient's own T cells, which have been treated in the lab, can help the body build an effective immune response to kill cancer cells.

Who is the study for?

This trial is for patients with specific B cell leukemias or lymphomas that have either returned after treatment or didn't respond to chemotherapy. They must be confirmed at MSKCC, expected to live more than 3 months, and meet certain health criteria like kidney function and blood counts.

What is being tested?

The study tests if T cells from the patient, modified in a lab to target cancer cells, combined with cyclophosphamide chemotherapy can effectively kill cancer cells. It's conducted in two stages: an initial safety study followed by a larger efficacy study.

What are the potential side effects?

Potential side effects may include immune system reactions due to modified T cells attacking normal tissue, typical chemo side effects like nausea and hair loss, increased infection risk, and possible organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart is strong enough for treatment (LVEF ≥40%).

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My leukemia or lymphoma is not responding to chemotherapy and has CD19+ B cells.

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My CLL diagnosis was confirmed through specific tests.

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My oxygen levels are 92% or higher without extra oxygen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart issues, including recent heart failure or heart attack.

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I have HIV, hepatitis B, or hepatitis C.

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My CLL has transformed into a more aggressive form.

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I am not currently receiving treatment for any other cancer besides the one being studied.

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I need assistance with my daily activities.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with CLL or indolent B-cell lymphomaExperimental Treatment2 Interventions

The first stage is a standard 3-step phase I dose escalation trial to assess the safety of 19-28z CAR expressing autologous T cells with or without prior conditioning chemotherapy.Step 1, a cohort of pts will receive the lowest planned dose of 19-28z+ modified T cells. Step 2, a cohort of pts will receive cyclophosphamide conditioning chemotherapy followed by the lowest planned dose of 19-28z+ modified T cells. If less than 33% of pts in the cohort experience unanticipated dose-limiting toxicity,Step 3, a cohort of pts will be treated with the investigator's choice conditioning chemotherapy followed by the higher dose of 19-28z+ modified T cells. If less than 33% of pts in the initial cohort (Step 3) experience unanticipated dose-limiting toxicity, the cohort in Step 3 may be expanded to include up to 15 pts. In Step 3, an additional cohort of Waldenstrom's Macroglobulinemia (WM) pts will be treated with the investigator's choice conditioning chemotherapy followed by 19-28z+ T cells.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

therapeutic autologous lymphocytes

2006

Completed Phase 2

~300

cyclophosphamide

1994

Completed Phase 3

~8140