NCT06195891View on ClinicalTrials.gov

Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome

PHASE1RecruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

May 24, 2024

Primary Completion Date

June 21, 2027

Study Completion Date

June 21, 2027

Conditions
Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndrome
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Dual-Energy Computed Tomography

Undergo DECT/MRI scan

PROCEDURE

Echocardiography

Undergo echocardiography

DRUG

Fludarabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo DECT/MRI scan

DRUG

Melphalan

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

BIOLOGICAL

Partially Engineered T-regulatory Cell Donor Graft TRGFT-201

Given IV

DRUG

Tacrolimus

Given tacrolimus

DRUG

Thiotepa

Given IV

RADIATION

Total Marrow and Lymphoid Irradiation

Undergo TMLI

Trial Locations (1)

91010

RECRUITING

City of Hope Medical Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER