Cellular Therapy for Acute Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byLeland Metheny, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Folashade Otegbeye

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to reduce the risk of cancer relapse by giving a donor lymphocyte infusion (DLI) to boost the immune system early after a stem cell transplant so that leukemia cells that escaped chemotherapy can be detected and killed. This DLI will contain mostly lymphocytes that have graft versus tumor effect with low risk of graft versus host disease. Because the process of giving a DLI in the first four weeks after a transplant has not been approved by the Food and Drug Administration (FDA), this study in investigational (experimental).

Research Team

Leland Metheny, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My transplant donor is at least 18 years old.

I need a stem cell transplant for my blood cancer.

My cancer diagnosis was confirmed through tissue or cell analysis.

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Exclusion Criteria

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

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

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

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Treatment Details

Interventions

Cellular therapy product (Cellular Therapy)

Trial OverviewThe 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.

Participant Groups

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.