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).
Acute myeloid leukemia [AML] in morphologic complete remission with intermediate/high-risk features (per NCCN criteria) or relapsed disease
Chronic myeloid leukemia [CML] in any chronic phase.
Myelodysplastic syndrome [MDS] with intermediate/high risk features or refractory disease (with bone marrow blast count <10%).
Acute lymphoblastic leukemia [ALL] in morphologic complete remission with high-risk features or relapsed disease.
Non-compliant patients.
No appropriate caregivers identified.
Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
Active central nervous system (CNS) neoplastic involvement.
Sequential
EAGD T-cell infusion (Phase I)
DrugThe 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)
DrugThe Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.
Phase I - Dose-limiting toxicity (DLT)
The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.
Phase I - Severe acute adverse events following infusion of EAGD T-cells
Safety of the infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Expansion phase - Rate of acute GVHD
Monitoring for GVHD is assessed with Grade II-IV adverse events as identified by the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Expansion phase - Relapse following haploidentical HCT and PTCy with EAGD T-cell infusion
Number of subjects who have acute GVHD by day 100 post-HCT after infusion of EAGD T-cells
Expansion phase - Non-relapse mortality following haploidentical HCT and PTCy with EAGD T-cell infusion
Number of subjects who have no relapse by day 100 post-HCT after infusion
Expansion phase - Overall survival following haploidentical HCT and PTCy with EAGD T-cell infusion
Number of subjects who are living by day 100 post-HCT after infusion
Rate of one-year relapse-free survival (RFS)
Number of subjects living without relapse of disease after one year following HCT
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University of Kansas Medical Center
Lead sponsor
In8bio Inc.
Collaborator
