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CAR T-cell Therapy

Gene-Modified T Cells for Acute Lymphoblastic Leukemia

Phase 1

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

Relapsed B-ALL and refractory patients are defined

Adult patients are eligible (> or = to 18 year old)

Must not have

Active central nervous system (CNS) leukemia within specific timeframe

Patients previously treated with an allogeneic SCT complicated by active GVHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an experimental treatment for leukemia that involves modifying immune cells called "T cells" to help them fight the cancer.

Who is the study for?

Adults over 18 with B-ALL leukemia that's resistant, relapsed, or in first complete remission can join. They need good heart and lung function, manageable blood chemistry levels, and a life expectancy over 3 months. Not allowed are those with recent heart attacks, severe heart failure, active GVHD from prior transplants, HIV/Hepatitis infections, active brain leukemia or other cancers needing treatment.

What is being tested?

The trial tests T cells genetically modified to target CD19 on leukemia cells after being reinfused into the patient. The study aims to find the safe dose of these T cells post chemotherapy which is given to reduce leukemia and help T cells last longer.

What are the potential side effects?

Potential side effects may include immune reactions due to modified T-cells attacking normal tissues (autoimmunity), symptoms related to infusion like fever or chills, and typical chemotherapy-related issues such as nausea, fatigue or increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My B-ALL cancer has returned or is not responding to treatment.

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I am 18 years old or older.

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I have been diagnosed with B-ALL.

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My leukemia cells test positive for CD19.

Exclusion Criteria

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

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My leukemia has spread to my brain or spinal cord recently.

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I had a stem cell transplant from a donor and am experiencing complications.

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I have HIV, hepatitis B, or hepatitis C.

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I have another active cancer besides the one being treated.

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I need assistance with my daily activities.

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I have a heart condition.

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: Pts with B Cell Acute Lymphoblastic LeukemiaExperimental Treatment1 Intervention

This is a phase I study. Patients with CD19+ ALL (CR, relapsed, MRD, or refractory) are eligible for enrollment. B-ALL patients in first CR will be enrolled but only treated if they develop MRD or a frank relapse, while patients with MRD or with documented relapsed/refractory disease are eligible for immediate treatment. The T cell doses originally proposed in this study were based on doses administered safely in prior autologous T cell adoptive therapy trials but the dose has been modified based on the toxicities observed in patients with morphologic evidence of disease. Patients will be treated with different doses of T cells depending on the amount of disease at the time of T cell infusion. Patients in Cohort 1 (\<5% blasts in the BM) will continue to receive 10\^6 19-28z+ T cells/kg as previously. Patients in Cohort 2 (≥5% blasts in the BM) will receive the reduced dose of 1x106 19-28z+ T cells/kg).

0 / 10Eligibility criteria met