Safety and Efficiency of ?9?2 T Cell Against Post-transplant Acute Leukemia/Myelodysplastic Syndrome Relapse
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This dose escalation study will be conducted in two phases. The first phase will have 3 cohorts(Dose escalation, x5 dose increments between cohorts, 2×10^6? 1×10^7/kg and 5×10^7 of cells per kg of body weight). The second phase is an expansion cohort at the maximum tolerated dose determined in the first phase.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded ?9?2 T-cells in patients with relapsed acute leukemia or myelodysplastic syndrome after allogeneic hematopoietic stem cell transplantation. ?9?2 T-cells will be separated from peripheral blo...
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded ?9?2 T-cells in patients with relapsed acute leukemia or myelodysplastic syndrome after allogeneic hematopoietic stem cell transplantation. ?9?2 T-cells will be separated from peripheral blood of suitable donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.
Tracking Information
- NCT #
- NCT04764513
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Chunji Gao, Professor Chinese PLA General Hospital Principal Investigator: Weidong Han, Professor Chinese PLA General Hospital
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