Genetically Modified T cells for Leukemia and Lymphoma

Overseen by Kevin Curran

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the safety of giving the patient special cells from a donor called "Modified T-cells". The goal is to assess the toxicities of T-cells for patients with relapsed B cell leukemia or lymphoma after a blood SCT organ SCT or for patients who are at high risk for relapse of their B cell leukemia or lymphoma.

Research Team

Kevin Curran

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

My cancer returned after a stem cell or organ transplant.

Pulmonary function: Oxygen saturation ≥ 90% on room air

Exclusion Criteria

I have health issues that make it hard for me to handle side effects.

I am an adult with a heart condition.

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

Treatment Details

Interventions

• Modified T-cells (CAR T-cell Therapy)

Trial Overview 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.

Participant Groups

Group I: Biological/Genetically Modified T cells Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University