NCT05735717 MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
| NCT ID | NCT05735717 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2023-05-11 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Margaret MacMillan
PRINCIPAL INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Frequently Asked Questions
Who can join the NCT05735717 clinical trial?
This trial is open to participants of all sexes, up to 60 Years, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05735717 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05735717 currently recruiting?
Yes, NCT05735717 is actively recruiting participants. Contact the research team at macmi002@umn.edu for enrollment information.
Where is the NCT05735717 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05735717 clinical trial?
NCT05735717 is sponsored by Masonic Cancer Center, University of Minnesota. The principal investigator is Margaret MacMillan at Masonic Cancer Center, University of Minnesota. The trial plans to enroll 70 participants.