MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

Recruiting now · Phase 2

Conditions studied: Hematologic Malignancy, Acute Leukemia, Remission, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, AML, TP53, Intrachromosomal Amplification of Chromosome 21, Cytogenetic Abnormality, CNS Leukemia, Minimal Residual Disease, Myelodysplasia, Juvenile Myelomonocytic Leukemia, Somatic Mutation, PTPN11 Gene Mutation, N-RAS Gene Amplification, Neurofibromatosis 1, NF1 Mutation, CBL Gene Mutation, Monosomy 7, Chromosome Abnormality, Fetal Hemoglobin, Lymphoblastic Lymphoma, High Grade Non-Hodgkin's Lymphoma, Adult

In brief

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.

Key facts

Study ID

NCT05735717

Run by

Masonic Cancer Center, University of Minnesota

People needed

70

Starts

2023-05-11

Expected to finish

2030-11-30

Last updated by the study team

2026-04-06

Who can join

Age: any, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of hematological malignancies
• Acute leukemias
• Acute Myeloid Leukemia (AML) and related precursor neoplasms
• Favorable risk AML is defined as having one of the following:
• Acute lymphoblastic leukemia (ALL)/lymphoma
• Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.
• Age 60 years of age or younger at the time of consent
• Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.
• Adequate organ function

You may not qualify if…

• Pregnant or breastfeeding.
• Active uncontrolled infection within 1 week of starting preparative therapy
• Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.
• Any prior autologous or allogeneic transplant
• CML blast crisis
• Active central nervous system malignancy

Where it is running

• University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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