Gamma Delta T-cell Therapy for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJoseph McGuirk, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults aged 19-65 with certain blood cancers like leukemia or myelodysplastic syndrome, who are in remission but at high risk of relapse and need a bone marrow transplant. They must have good heart, lung, liver, and kidney function and not be pregnant or HIV positive. People with uncontrolled infections or severe organ toxicity can't join.

Inclusion Criteria

I have a blood cancer that requires a stem cell transplant.

My heart, lungs, and kidneys are functioning well, and I have no severe infections or organ toxicity.

I am between 19 and 65 years old.

Exclusion Criteria

Pregnant or breastfeeding women

Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies

Patients with known allergy to DMSO

See 5 more

Treatment Details

Interventions

EAGD T-cell infusion (Cell Therapy)

Trial OverviewThe study tests infusions of expanded/activated gamma delta T-cells after a partially mismatched bone marrow transplant to fight cancer cells while trying to prevent graft versus host disease in patients with specific leukemias and myelodysplastic syndrome.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: EAGD T-cell infusion (Phase I)Experimental Treatment1 Intervention

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.

Group II: EAGD T-cell infusion (Expansion)Experimental Treatment1 Intervention

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.