Phase 1/1b Trial of Donor gamma delta T-cell Infusion for Treatment of Patients with Acute Myeloid Leukemia at High Risk of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation
The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).
Primary: 1) The primary objective of this study dose finding phase is to determine the maximal tolerated dose (MTD) of AAPC-expanded donor γδ T-cells administered after alloHCT as a single infusion to AML patients with MRD detectable disease. 2) The primary objective of the extension phase is to assess the potential efficacy of AAPC expanded donor γδ T-cells in AML patients with MRD detectable disease. Secondary: 1) Assess the quality of donor γδ T-cell production. 2) Determine the incidence of grade II-IV and III-IV acute GVHD within 6 weeks after infusion of γδ T cells. 3) Assess the effect of AAPC expanded donor γδ T-cells on hematological relapse and OS at 1-year after infusion of γδ T-cells.
Donor T Cells ()
- Inclusion Criteria:
- Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment of Acute Myeloid Leukemia (AML) with detectable minimal residual disease (MRD) either before or after alloHCT
- Have > Karnofsky performance status (KPS) ≥ 70% during the study screening.
- Free of symptomatic congestive heart failure or uncontrolled arrhythmia
- Adequate organ function as defined in protocol
- Negative serum pregnancy test Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Exclusion Criteria:
- Current use of concomitant systemic glucocorticoid for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ T-cell function.
- Active grade II-IV acute GVHD (patients with prior GVHD should be off prednisone for at least 14 days prior to infusion of the study cell product).
- Uncontrolled serious infection.
- Morphologic relapse of leukemia at any timepoint after HCT.
- Active central nervous system malignancy.
- Pregnancy or lactation.
- Treatment with another investigational drug or other intervention within 14 days of T-cell infusion
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.