Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors
NCT05755854 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-09-22
Summary
This is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.
Conditions
Interventions
- BIOLOGICAL
-
allogeneic γ9δ2 T Cells
dose escalation (3+3) : dose 1 (5 × 10\^7cells/kg) ,dose 2 (1 × 10\^8 cells/kg) ,dose 3 (2 × 10\^8cells/kg)
- DRUG
-
Intravenous fludarabine on days-5 and -4,the infusion dose is adjusted according to the subject's condition
- DRUG
-
Intravenous cyclophosphamide on days -5、-4、and -3, the infusion dose is adjusted according to the subject's condition
- DRUG
-
Zoredronic acid
Intravenous zoredronic acid 50ug/kg 24 hours before cell infusion(or according to the dosage of the instruction)(If applicable)
Sponsors & Collaborators
-
Anhui Provincial Hospital
lead OTHER_GOV
Principal Investigators
-
Zhu Xiaoyu, Ph.D · Director of Hematology Department, Anhui Provincial Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-03
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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