Anti-BCMA CAR-NK Cell Therapy for the Relapsed or Refractory Multiple Myeloma
NCT05008536 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2021-11-23
Summary
The purpose of this study is to infuse BCMA CAR-NK cells(Umbilical \& Cord Blood (CB) Derived CAR-Engineered NK Cells) to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
Conditions
- Multiple Myeloma, Refractory
Interventions
- BIOLOGICAL
-
Anti-BCMA CAR-NK Cells
1-3×10\^6 /KG, 3-6×10\^6 /KG, 0.6-1.2×10\^7/KG Treatment follows a lymphodepletion
- DRUG
-
recommendation: 30mg/m2 (D-5\~D-3),determined by tumor burden at baseline.
- DRUG
-
Cytoxan
recommendation: 300-500mg/m2 (D-5\~D-3),determined by tumor burden at baseline.
Sponsors & Collaborators
-
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
collaborator INDUSTRY -
Xinqiao Hospital of Chongqing
lead OTHER
Principal Investigators
-
xi zhang, PhD/MD · Department of Hematology, Xinqiao Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-01
- Primary Completion
- 2022-09-01
- Completion
- 2023-09-01
Countries
- China
Study Locations
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