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CAR T-cell Therapy

Genetically Modified T cells for Leukemia and Lymphoma

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

Relapse on this protocol is detection of CD19+ malignancies in bone marrow morphology ≥ 5% any extramedullary lesion (radiographic), or detection of any disease level by cytogenetics, molecular, and/or flow cytometry

History of CD19+ relapse/refractory (R/R) B cell malignancies occurring after allogeneic/autologous HSCT or solid organ transplant (SOT) (cohort 1)

Must not have

Adult patients with specific cardiac conditions

Patients with active 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 the safety of giving patients modified T-cells from a donor. The goal is to see if these cells cause any toxicities in patients with relapsed B cell leukemia or lymphoma.

Who is the study for?

This trial is for patients with B-cell leukemia or lymphoma who have had a stem cell transplant or are at high risk of relapse. They must have proper kidney, liver, heart, and lung function. It's not for those with active HIV/hepatitis infections, other cancers needing treatment, pregnant women, severe heart conditions, uncontrolled illnesses that could worsen side effects from the therapy.

What is being tested?

The study tests the safety of Modified T-cells from donors targeting CD19 antigen in patients with relapsed B-cell malignancies post-transplant or at high risk of relapse. The focus is on assessing toxicities related to these genetically modified cells after chemotherapy conditioning.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as cytokine release syndrome (flu-like symptoms), neurological issues (headaches, confusion), and typical risks associated with chemotherapy like fatigue and increased infection susceptibility.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned and tests show more than 5% cancer cells in my bone marrow or any cancer presence detected by specific tests.

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My cancer returned after a stem cell or organ transplant.

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My liver tests are within the required limits.

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I can do most of my daily activities by myself.

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My kidney function is normal, with creatinine levels within the required range.

Exclusion Criteria

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

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I am an adult with a heart condition.

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I have an active HIV, hepatitis B, or hepatitis C infection.

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I do not have any uncontrolled illnesses causing symptoms.

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I haven't had chemotherapy in the last 2 weeks.

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

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I am currently receiving steroids for active graft versus host disease or autoimmune disease.

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My condition is worsening quickly and may prevent me from completing the treatment.

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My leukemia has returned outside the bone marrow.

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: Biological/Genetically Modified T cellsExperimental Treatment2 Interventions

Utilizing our initial trial experience, it was amended to include three (3) expansion cohorts. Cohort 1: patients with CD19+ relapse/refractory (R/R) B cell malignancies occurring after allogeneic/autologous HSCT or solid organ transplant (SOT) infusion occurring following conditioning chemotherapy. Cohort 2:patients with CD10+ high risk B cell malignancies eligible for autologous HSCT followed by 19-28z CRA EBV-CTLs (auto-HSCT preparative regimen serves as conditioning chemotherapy. Cohort 3: patients with CD19+ high risk B cell malignancies eligible for allogeneic HSCT followed by consolidative 19-28z CAR EBV-CTLs (allo-HSCT preparative regimen serves as conditioning chemotherapy) Each expansion cohort has a target accrual of 6 patients treated with fixed CAR EBV-CTL dose (3x106 EBV-CTLs/kg) which has been demonstrated to be the ideal manufacturing dose.

0 / 13Eligibility criteria met