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Cell Therapy

Gamma Delta T-cell Therapy for Leukemia

Phase 1

Recruiting

Led By Joseph McGuirk, M.D.

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines

Organ Function Criteria: Normal left ventricular ejection fraction (LVEF) (50% or above), FVC, FEV1 and DLCO (corrected) should be 50% or above of expected, serum creatinine level to be <2 mg/dl, serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN, alkaline phosphatase 2.5 ULN, Karnofsky performance score (KPS) or Lansky score: ≥80, Hematopoietic cell transplant comorbidity index (HCT-CI) <3, informed consent obtained, Absence of uncontrolled infection with sepsis syndrome, NO hemodynamic instability, NO clinically significant organ toxicity, Neutrophil engraftment

Must not have

Active central nervous system (CNS) neoplastic involvement

Morbid obesity with body mass index >35

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to one year

Awards & highlights

No Placebo-Only Group

Summary

This trial uses gamma delta T-cells to kill cancer cells while minimizing GVHD in patients who have had a partially mismatched bone marrow transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the infusion such as fever or chills, increased risk of infection due to immune system changes, possible organ inflammation from immune responses, and complications related to graft versus host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 19 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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My BMI is over 35, indicating morbid obesity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Expansion phase - Rate of acute GVHD

Phase I - Dose-limiting toxicity (DLT)

Phase I - Severe acute adverse events following infusion of EAGD T-cells

Secondary study objectives

Expansion phase - Non-relapse mortality following haploidentical HCT and PTCy with EAGD T-cell infusion

Expansion phase - Overall survival following haploidentical HCT and PTCy with EAGD T-cell infusion

Expansion phase - Relapse following haploidentical HCT and PTCy with EAGD T-cell infusion

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

508 Previous Clinical Trials

174,446 Total Patients Enrolled

In8bio Inc.Industry Sponsor

2 Previous Clinical Trials

25 Total Patients Enrolled

Joseph McGuirk, M.D.3.515 ReviewsPrincipal Investigator - University of Kansas Medical Center

University of Kansas Medical Center

5Patient Review

Dr. McGuirk is an excellent physician who exudes both confidence and compassion. We wholeheartedly trust his judgement and are grateful for the positive difference he has made in our lives!