Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    32
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 10 May 2022
cell transplantation
minimal residual disease
residual tumor
blast cells

Summary

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).

Details
Condition Acute Myeloid Leukemia
Treatment Gamma Delta T-Cell Infusion
Clinical Study IdentifierNCT05015426
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML
Have < 5% blasts in bone marrow by morphology at the time of transplantation. Patients with pre-alloHCT or post-alloHCT flow cytometric or molecular evidence of MRD are allowed
Karnofsky performance status (KPS) ≥ 70% during the study screening
Free of symptomatic congestive heart failure or uncontrolled arrhythmia
Adequate organ function as defined per 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 at the time of γδ T-cell infusion 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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