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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year from start of treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Folashade OtegbeyeLead Sponsor
Leland MethenyLead Sponsor
4 Previous Clinical Trials
60 Total Patients Enrolled
Folashade Otegbeye, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Media Library

Cellular therapy product (Cellular Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03939585 — Phase 1
Stem Cell Transplant Research Study Groups: NK/γδ T cell-enriched cell therapy product
Stem Cell Transplant Clinical Trial 2023: Cellular therapy product Highlights & Side Effects. Trial Name: NCT03939585 — Phase 1
Cellular therapy product (Cellular Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03939585 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are you enrolling people in this research program at the moment?

"Unfortunately, this particular study is not recruiting patients at the moment. Although it was last updated on July 1st, 2022, the trial was originally posted on September 1st, 2022. There are, however, 540 other trials that are looking for participants right now."

Answered by AI

Has the Cellular therapy undergone FDA approval?

"Because a Cellular therapy product is in Phase 1 of clinical trials, there is limited data supporting both its efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Preemptive Infusion of Donor Lymphocytes Depleted of TCR + T Cells + CD19+ B Cells Following ASCT
Leland Metheny 2024. "Preemptive Infusion of Donor Lymphocytes Depleted of TCR + T Cells + CD19+ B Cells Following ASCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03939585.
~7 spots leftby Jun 2025
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