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CAR T-cell Therapy

Modified T-Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1

Waitlist Available

Led By Kevin Curran, 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

CNS-3 leukemia at diagnosis

t(17;19) ALL or Ph-Like ALL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if it's safe to give leukemia patients their own modified blood cells. The goal is to find a safe dose.

Who is the study for?

This trial is for pediatric and young adult patients with a relapse of B-cell acute lymphoblastic leukemia. Eligible participants include those diagnosed at age ≥13 years, with specific genetic markers or high-risk features, and who are in their first or subsequent bone marrow relapse.

What is being tested?

The study tests the safety of modified T-cells made from the patient's own blood to treat leukemia that has returned. It aims to determine a safe dose for these special cells after standard chemotherapy regimens.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, drop in blood pressure, difficulty breathing, and organ inflammation. Chemotherapy can cause nausea, hair loss, mouth sores, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia was CNS-3 at diagnosis.

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My leukemia is either t(17;19) ALL or Ph-Like ALL.

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I was diagnosed with high-risk acute lymphoblastic leukemia at 13 or older.

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My cancer cells have fewer than 44 chromosomes or a low DNA index.

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My cancer has an MLL gene rearrangement.

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My leukemia is Philadelphia chromosome positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

safety

Secondary study objectives

assess the persistence of modified T cells

the development of B cell aplasia

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (Morphologic Disease)Experimental Treatment3 Interventions

Pts with morphologic evidence of disease at the time of T cell infusion, (≥5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Pts with increased blasts (5-10% blasts) that are immunophenotypically consistent with recovering marrow from prior re-induction chemo may be treated under Cohort 1 with approval of the participating site PI. Cohort 2 pts will get conditioning chemo followed by 1x10\^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of EOP T cells, under or over estimation of CAR modified T-cells may occur. Pts may get up to 35% over total cell dose with approval by the participating site PI. Both cohorts, pts will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion \& did not experience any non-hematologic grade 4 toxicities.

Group II: Cohort 1 (MRD)Experimental Treatment3 Interventions

Patients with no morphologic evidence of disease at the time of T cell infusion, (\<5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Cohort 1 patients will receive conditioning chemotherapy followed by 1x10\^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of End of Production (EOP) T cells, under or over estimation of CAR modified T-cells may occur. Patients may receive an altered fractionation of the total doses (e.g. ½ on Day 0 and ½ on Day +1) or up to 35% over total cell dose with approval by the participating site PI. In both cohorts, patients will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion and did not experience any non-hematologic grade 4 toxicities.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

modified T cells

2011

Completed Phase 1

~20

0 / 6Eligibility criteria met