Gamma Delta T-cell Therapy for Leukemia

Overseen By Clinical Trial Nurse Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Kansas Medical Center

Disqualifiers: CNS involvement, Morbid obesity, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

38 Participants Needed

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).

Research Team

Joseph McGuirk, M.D.

Principal Investigator

University of Kansas Medical Center

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hematopoietic Stem Cell Transplantation

Participants undergo haploidentical hematopoietic stem cell transplantation

1 week

Post-transplant Cyclophosphamide

Participants receive post-transplant cyclophosphamide to minimize graft versus host disease

1 week

EAGD T-cell Infusion (Phase I)

Infusion of expanded/activated gamma delta T-cells at varying concentrations to determine maximum tolerated dose

100 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of GVHD and overall survival

1 year

Treatment Details

Interventions

• EAGD T-cell infusion

Trial Overview The 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

Group I: EAGD T-cell infusion (Phase I) Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

In8bio Inc.

Industry Sponsor

Trials

3

Recruited

60+