Actively Recruiting
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
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-08-30
36
Participants Needed
1
Research Sites
34 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
Researchers are evaluating the safety and effectiveness of CD123-targeted CAR-NK cell preparations in patients with relapsed or refractory acute myeloid leukemia (AML) or blastic plasmacytoid dendritic cell neoplasm (BPDCN). This is a single-arm, open-label study with dose escalation and dose expansion phases. The study aims to understand how these CAR-NK cells behave in the body and to find the recommended dose for treating these conditions. The study divides participants into two groups based on their disease: AML and BPDCN. Each group has a dose exploration stage where low doses are tested in three patients, followed by a dose expansion stage to further evaluate safety and effectiveness at the recommended dose. Participants receive intravenous infusions of CD123-targeted CAR-NK cells at doses ranging from 1 to 10 million cells per kilogram. Before infusion, patients undergo conditioning therapy with Fludarabine and Cyclophosphamide. Participants will be monitored closely for safety and response to treatment, with assessments including measuring the safety and effectiveness of CAR-NK cells at 1 and 3 months. Researchers will also study how the CAR-NK cells behave in the body over 3 months, including their concentration and activity. The study period includes monitoring adverse effects and overall treatment impact. The total age range for participation is 18 to 75 years old.
CONDITIONS
Brief 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 values)
- CD123 expression detected in tumor cells by flow cytometry
- Diagnosis of relapsed or refractory AML or BPDCN with CD123 positive tumor cells
- Expected survival time more than 12 weeks
- ECOG performance status of 0 to 2
- No serious mental disorders and basically normal important organ functions including cardiac ejection fraction ≥50%, serum creatinine ≤2.0×ULN, liver enzymes ALT and AST ≤3.0×ULN, bilirubin and alkaline phosphatase ≤2.0×ULN (Gilbert syndrome ≤3.0×ULN), and blood oxygen saturation >92%
- Patient or guardian agrees to participate and signs informed consent form
You will not qualify if you...
- Received chemotherapy, targeted therapy, or investigational drugs within 14 days or less than 5 half-lives before screening unless disease progression confirmed
- Had cerebrovascular accident or seizure within 6 months before consent
- Active or uncontrolled infection requiring systemic treatment within 1 week before screening
- Heart diseases including NYHA Stage III or IV heart failure, myocardial infarction or coronary artery bypass graft within 6 months, significant ventricular arrhythmia or unexplained syncope, severe non-ischemic cardiomyopathy
- Active hepatitis B
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Other malignancies except certain treated cancers
- 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 treatment
- Any other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants receive conditioning therapy followed by infusion of CD123-targeted CAR-NK cells to treat relapsed or refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm.
1 conditioning therapy visit and 1 infusion visit
Duration - Up to 3 months
Participants are monitored for safety and efficacy outcomes after treatment.
Regular visits during 3 months for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
J
Jia Wei, M.D
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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