Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

Part of paid clinical trials in Westwood, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT03533816
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • EAGD T-cell infusion (Phase I) — DRUG
    The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.
  • EAGD T-cell infusion (Expansion) — DRUG
    The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.

Study Details

Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical).

Key Dates

Start date
Jan 31, 2020
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: EAGD T-cell infusion (Phase I)
    Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at either 1, 3, or 10 x 1,000,000 cells/kg concentrations depending upon the cohort.
  • Experimental: EAGD T-cell infusion (Expansion)
    Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at the maximum tolerated dose as determined from Phase I.

Primary Outcome Measure

Phase I - Dose-limiting toxicity (DLT) [ Time Frame: Baseline to Day 30 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterWestwoodKansas66205
Clinical Trials Nurse Navigator
[email protected]
913-945-7552
Joseph McGuirk, M.D.
[email protected]
913-588-6030
Ohio State University Medical CenterColumbusOhio43210-1238-

Find similar trials in Westwood, KS

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Kansas Cancer Center· Westwood, KSOhio State University Medical Center· Columbus, OH

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