Trials / Recruiting
RecruitingNCT06006403
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Clinical Study of Targeting CD123 Chimeric Antigen Receptor Natural Killer Cells (CAR-NK) in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Chongqing Precision Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed/refractory acute myeloid leukemia (AML) or blastocytic plasmacytoid dendritic cell neoplasm (BPDCN). The pharmacokinetic characteristics of CAR-NK cell preparations for the treatment of patients with Relapsed/refractory acute myeloid leukemia or blastocytic plasmacytoid dendritic cell neoplasm were obtained and the recommended dose.
Detailed description
According to the different disease type, it is divided into two subgroups: AML and BPDCN. Each subgroup includes a dose exploration stage (Part A) and a dose expansion stage (Part B). 3 patients were explored, starting from the low-dose group, and in the dose expansion phase, the safety and efficacy were further verified according to the safe recommended dose obtained in the dose exploration phase.
Conditions
- Acute Myeloid Leukemia
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- Relapse Leukemia
- Refractory Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD123 targeted CAR-NK cells | Administration method: intravenous infusion； Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion. |
Timeline
- Start date
- 2023-08-31
- Primary completion
- 2025-12-31
- Completion
- 2026-08-31
- First posted
- 2023-08-23
- Last updated
- 2023-08-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06006403. Inclusion in this directory is not an endorsement.