A Study of Universal CD19-Targeted UCAR-NK Cells Combined With HSCT for B Cell Hematologic Malignancies
NCT05654038 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-12-21
Summary
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 universal CAR-NK(UCAR-NK) cells therapy combined with HSCT for B cell hematologic malignancies.
Conditions
- B-Cell Lymphoblastic Leukemia/Lymphoma
Interventions
- BIOLOGICAL
-
Anti-CD19 UCAR-NK cells
The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of UCAR-NK cells:Dose level one: 5-10×10\^6/kg; Dose level two:1-2×10\^7/kg; Dose level three:2-5×10\^7/kg.
Sponsors & Collaborators
-
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
lead OTHER
Principal Investigators
-
Sanbin Wang, MD · 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-08
- Primary Completion
- 2023-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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