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Cellular Therapy

Cellular Therapy for Acute Leukemia

Phase 1

Waitlist Available

Led By Folashade Otegbeye, MD

Research Sponsored by Folashade Otegbeye

Eligibility Criteria Checklist

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

Must have

The related transplant donor is 18 years of age or older

Allogeneic stem cell transplant is indicated as management of underlying hematologic malignancy.

Must not have

Subject is unwilling to receive a prophylactic donor lymphocyte infusion per study protocol

Patients with any of the following organ function abnormalities: Left ventricular ejection fraction (LVEF) < 45%; DLCO <45% of expected value corrected for alveolar volume and hemoglobin; Serum Creatinine >2 times the upper limit of normal.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year from start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving a donor lymphocyte infusion early after a stem cell transplant can reduce the risk of cancer relapse by boosting the immune system.

Who is the study for?

This trial is for individuals with certain blood cancers who are undergoing a stem cell transplant and have a matched sibling or half-matched donor. Participants must be adults with good heart, lung, and liver function, able to give consent, and willing to use effective contraception. Those unwilling to receive the study's DLI or lacking an available donor cannot join.

What is being tested?

The trial tests a cellular therapy product: a special infusion of donor lymphocytes designed to boost the immune system after stem cell transplant. This aims to prevent cancer relapse by targeting remaining leukemia cells without causing severe graft versus host disease.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as mild graft versus host disease symptoms where the body might react against these new cells, but specific side effects will be monitored given this is an experimental approach.

Eligibility Criteria

Inclusion Criteria

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

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My transplant donor is at least 18 years old.

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I need a stem cell transplant for my blood cancer.

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My cancer diagnosis was confirmed through tissue or cell analysis.

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My transplant donor agrees to a second leukapheresis procedure.

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I need a stem cell transplant for my blood cancer.

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My heart, lungs, and liver are strong enough for chemotherapy and a stem cell transplant.

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I have a sibling or a half-matched donor for my transplant.

Exclusion Criteria

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

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I do not want to receive a preventive immune cell transfusion as part of the study.

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My heart, lungs, or kidneys are not functioning well.

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My related donor cannot or will not provide a second sample of white blood cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year from start of treatment

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

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Grade III-IV GVHD, Grade II GVHD requiring systemic treatment or new onset, severe neutropenia requiring growth factor support at Day 100 and T+6 months.

Secondary study objectives

Average time to disease relapse from date of transplant

Average time to first occurrence of reactivated EBV and/or CMV

Different lymphocyte types in the infused product reported as cells per kilogram body weight of the recipient

+3 more

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: NK/γδ T cell-enriched cell therapy productExperimental Treatment1 Intervention

This study will treat 10 participants with the donor NK/TCR-γδ T cell product. Of those 10 participants, 5 would have 10/10 HLA matched sibling donors (MSD) while 5 would have partially matched, related (haplo) donors. * 27 days post transplant, the participant's donor will undergo a second, non-mobilized leukapheresis to obtain peripheral blood mononuclear cells (PBMCs). * Donor PBMCs will be processed next day (Day T+28) to obtain the NK cell/TCRγδ T cell product for same day infusion if the participant remains aGVHD free and clinically stable. * Participants will continue routine post-transplant and GVHD monitoring, as well as disease assessment at 56 days, 100 days, 6 months and 1 year following transplant. * Blood samples will be obtained on T=0, T+7, 14, 21 and 28 days and then weekly until T + 56 days, then on T+100 days, + 6 months and + 12 months. If immune-mediated adverse events occur (GVHD, CRS etc) additional blood samples will be obtained at onset and resolution.

0 / 10Eligibility criteria met