Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT03533816

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

Led by University of Kansas Medical Center · Updated on 2026-03-25

38

Participants Needed

2

Research Sites

413 weeks

Total Duration

On this page

Sponsors

U

University of Kansas Medical Center

Lead Sponsor

I

In8bio Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with neoplastic hematological disorders needing allogeneic transplant per guidelines
  • Acute myeloid leukemia in complete remission with intermediate/high-risk or relapsed disease
  • Chronic myeloid leukemia in any chronic phase
  • Myelodysplastic syndrome with intermediate/high risk or refractory disease (bone marrow blasts <10%)
  • Acute lymphoblastic leukemia in complete remission with high-risk or relapsed disease
  • Negative donor-specific antibody test within 28 days before conditioning
  • Age between 19 and 65 years
  • Normal cardiac function with LVEF 50% or above
  • Pulmonary function (FVC, FEV1, DLCO) 50% or above of expected
  • Renal function with serum creatinine <2 mg/dl and creatinine clearance ≥70 mL/min/1.73 m2
  • Liver function with bilirubin ≤1.5 ULN, AST/ALT ≤2.5 ULN, alkaline phosphatase ≤2.5 ULN
  • Karnofsky or Lansky performance score 80 or higher
  • Hematopoietic cell transplant comorbidity index less than 3 (exceptions possible)
  • Informed written consent given
  • No uncontrolled infection or sepsis within 48 hours before infusion
  • No hemodynamic instability or circulatory volume overload
  • No significant organ toxicity such as heart failure, elevated creatinine, liver enzyme elevations >5x ULN, or hypoxemia needing oxygen
  • No acute graft versus host disease
  • Neutrophil engraftment achieved
Not Eligible

You will not qualify if you...

  • Non-compliant patients
  • No suitable caregivers identified
  • Uncontrolled medical or psychiatric disorders preventing study participation
  • Active central nervous system cancer involvement
  • Morbid obesity with BMI over 35 (case-by-case exceptions possible)
  • Known allergy to DMSO
  • HIV1 or HIV2 positive
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Actively Recruiting

2

Ohio State University Medical Center

Columbus, Ohio, United States, 43210-1238

Actively Recruiting

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Research Team

C

Clinical Trial Nurse Navigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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