Actively Recruiting
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-08-30
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
S
Shanxi Bethune Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gender is not limited, age 18-75 years old (including the threshold value)
- CD123 expression detected in tumor cells by flow cytometry
- Diagnosis of relapsed or refractory AML or BPDCN with CD123 positivity:
- AML: recurrent leukemia with 5% leukemia cells in blood or bone marrow after complete response or extramedullary infiltration; refractory after failing 2 standard treatments; recurrence within 12 months after consolidation; recurrence after 12 months unresponsive to chemotherapy; 2 or more relapses; persistent extramedullary leukemia
- BPDCN: failed or intolerant to guideline-recommended salvage therapy with persistent or recurrent disease in blood, bone marrow, lymph nodes, spleen, skin, or other sites
- Expected survival time more than 12 weeks
- ECOG performance status 0-2
- No serious mental disorders
- Normal important organ functions:
- Cardiac ejection fraction 50% and no ECG abnormalities
- Serum creatinine 2.0 upper limit of normal (ULN)
- ALT and AST 3.0 ULN
- Total bilirubin and alkaline phosphatase 2.0 ULN (Gilbert syndrome 3.0 ULN)
- Blood oxygen saturation >92%
- Patient or guardian agrees to participate and signs informed consent
You will not qualify if you...
- Received chemotherapy, targeted therapy, or investigational drugs within 14 days or 5 half-lives before screening unless disease progression confirmed
- Had a stroke or seizure within 6 months before consent
- Active or uncontrolled infection requiring systemic treatment within 1 week before screening
- Serious heart diseases including NYHA stage III/IV heart failure, myocardial infarction or bypass surgery within 6 months, significant ventricular arrhythmia, unexplained syncope, or severe non-ischemic cardiomyopathy
- Active hepatitis B infection
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Other malignancies except adequately treated cervical carcinoma in situ, skin basal or squamous cell cancer, local prostate cancer after surgery, or ductal carcinoma in situ after surgery
- Received live attenuated vaccine within 4 weeks before screening
- Pregnant or breastfeeding women, or planning to have a family within 1 year after CAR T cell transfusion
- Other conditions deemed unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
J
Jia Wei, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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