Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
NCT04764513 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-03-28
Summary
This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.
Conditions
Interventions
- BIOLOGICAL
-
Ex-vivo expanded γδ T cell infusion
Phase 1: Patients receive ex-vivo expanded γδ T cell (Dose escalation, 3 cohorts, x5 dose increments between cohorts, 2×10\^6、 1×10\^7 and 5×10\^7 of cells per kg of body weight). Phase 2: Patients receive ex-vivo expanded γδ T cell at the maximum tolerated dose determined in Phase 1.
Sponsors & Collaborators
-
Chinese PLA General Hospital
lead OTHER
Principal Investigators
-
Chunji Gao, Professor · Chinese PLA General Hospital
-
Weidong Han, Professor · Chinese PLA General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-12
- Primary Completion
- 2023-04-30
- Completion
- 2025-04-30
Countries
- China
Study Locations
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