Actively Recruiting
Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) for Relapsed or Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2024-11-15
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of anti-CD123 CAR-NK cell therapy for patients with relapsed or refractory acute myeloid leukemia (AML) or blastic plasmacytoid dendritic cell neoplasm (BPDCN). This phase 1, single-arm, open-label trial aims to find the best dose of this cell therapy for these difficult-to-treat conditions. The study focuses on patients whose tumor cells express the CD123 marker and who have limited treatment options due to relapse or resistance to standard therapies. Participants will receive two infusions of anti-CD123 CAR-NK cells, given seven days apart. The study includes three dosage groups: 1x10^7, 3x10^7, and 5x10^7 CAR-positive cells per kilogram of body weight. The dose for the second infusion may be adjusted based on each patient's condition, and the cells must be infused within 70 minutes after thawing. This dose-finding approach helps determine the recommended treatment level for future use. During the trial, patients will be closely monitored for safety and treatment response. Researchers will track side effects occurring within 28 days and measure responses such as complete or partial remission over the first three months. Long-term outcomes including overall survival, duration of response, recurrence-free survival, and event-free survival will be followed for up to two years. Various laboratory tests, imaging, and clinical assessments will be conducted to evaluate the therapy's impact and patients' health throughout the study period.
CONDITIONS
Brief Title
Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any gender, aged between 18 and 75 years (inclusive)
- Positive expression of CD123 on tumor cells detected by flow cytometry
- Confirmed diagnosis of CD123-positive relapsed or refractory AML or BPDCN
- Expected survival time of more than 12 weeks
- ECOG score of 0 to 2
- No severe mental disorders
- Adequate organ function including blood, heart, kidney, liver, and blood oxygen saturation levels
- Patient or legal guardian agrees and signs informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Active central nervous system invasion at screening
- Anti-tumor therapies within 14 days prior to screening except for confirmed disease progression
- Cerebrovascular accident or epileptic seizure within 6 months prior to screening
- Active or uncontrolled infection requiring systemic treatment within 1 week prior to screening
- Significant cardiac diseases including severe heart failure, recent heart attack or surgery, serious arrhythmia, or severe cardiomyopathy
- Active autoimmune diseases needing long-term immunosuppressive therapy
- Other malignancies except certain treated localized cancers
- Live attenuated vaccines within 4 weeks prior to screening
- Pregnant or breastfeeding women and those planning pregnancy within 1 year after treatment
- Any other condition deemed unsuitable by the investigator
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) for screening and enrollment
Duration - 1 week
Participants receive two infusions of anti-CD123 CAR-NK cells on Day 0 and Day 7. The dose for the second infusion may be adjusted based on participant condition.
2 visits (in-person) for infusions on Day 0 and Day 7
Duration - Up to 2 years
Participants are monitored for safety, response, and survival outcomes for up to 2 years after treatment.
Regular visits for assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
W
Wei Jia, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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