Description:
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).
Title
- Brief Title: Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT
- Official Title: Phase 1/1b Trial of Donor γδ T--Cell Infusion for Treatment of Patients With Acute Myeloid Leukemia at High Risk of Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Clinical Trial IDs
- ORG STUDY ID:
MCC-20305
- NCT ID:
NCT05015426
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Gamma Delta T-Cell Infusion | | Dose Level -1 |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Level -1 | Experimental | Dose Level -1 may be used as a de-escalation dose level due to Dose Limiting Toxicities (DLTs) from Dose Level 1
Participants will receive 1.0 x 106 cells/kg (0.75-1.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion | - Gamma Delta T-Cell Infusion
|
Dose Level 1 | Experimental | Participants will receive 5.0 x 106 cells/kg (3.75-6.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion | - Gamma Delta T-Cell Infusion
|
Dose Level 2 | Experimental | Participants will receive 2.5 x 107 cells/kg (1.875-3.125 x 107 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion | - Gamma Delta T-Cell Infusion
|
Dose Level 3 | Experimental | Participants will receive 1.0 x 108 cells/kg (0.75-1.25 x 108 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion | - Gamma Delta T-Cell Infusion
|
Treatment at Maximum Tolerated Dose | Experimental | Participants will receive Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells at the dose determined to be the Maximum Tolerated Dose, administered as a single infusion | - Gamma Delta T-Cell Infusion
|
Eligibility Criteria
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 < 5% blasts in bone marrow by morphology at the time of transplantation but
pre-alloHCT flow cytometric or molecular evidence of MRD
- 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 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
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose |
Time Frame: | Up to 12 months |
Safety Issue: | |
Description: | Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells. |
Secondary Outcome Measures
Measure: | Number of Participants with Graft Versus Host Disease (GVHD) |
Time Frame: | at 6 weeks |
Safety Issue: | |
Description: | Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 12 months |
Safety Issue: | |
Description: | The length of time from start of treatment to death by any cause. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Trial Keywords
Last Updated
August 30, 2021