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

Acute Myeloid Leukemia Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05015426
• Other study ID #: MCC-20305
• Secondary ID: 9BC08
• Status: Recruiting
• Phase: Phase 1
• Start date: March 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?d T-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on ?d 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• Gamma Delta T-Cell Infusion
Donor cells will be processed in a laboratory, where T-cell subtype called ?d (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor ?d T-cells.	Up to 12 months
Primary	Dose Expansion: Leukemia Free Survival	Leukemia-free survival is defined as the time from the date of start of treatment to the date of relapse of AML or death from any cause	Up to 12 months
Secondary	Number of Participants with Graft Versus Host Disease (GVHD)	Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells	at 6 weeks
Secondary	Overall Survival (OS)	The length of time from start of treatment to death by any cause.	Up to 12 months