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Trial Title:
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
NCT ID:
NCT06006403
Condition:
Acute Myeloid Leukemia
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Relapse Leukemia
Refractory Leukemia
Conditions: Official terms:
Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD123 targeted CAR-NK cells
Description:
Administration method: intravenous infusion； Subjects will receive conditioning therapy
by Fludarabine and Cyclophosphamide before cell infusion.
Arm group label:
Acute Myeloid Leukemia
Arm group label:
Blastic Plasmacytoid Dendritic Cell Neoplasm
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Gender is not limited, age 18-75 years old (including the threshold value);
2. The expression of CD123 in tumor cells was detected by flow cytometry.
3. Patients with relapsed/refractory AML or BPDCN diagnosed with CD123 positive: 1)
AML: a. Recurrent: After complete response (CR), the recurrence of leukemia cells in
peripheral blood or bone marrow original cells ≥5% (except for other reasons such as
bone marrow regeneration after consolidation chemotherapy) or the occurrence of
extramedullary leukemia cell infiltration; b. Refractory: refers to those who have
failed to receive 2 courses of treatment with standard protocols; Patients
recurrence within 12 months after CR with consolidation and intensive treatment;
Recurrence after 12 months but failed to respond to conventional chemotherapy; 2 or
more relapses; Extramedullary leukemia persists;
2) BPDCN: has failed to receive guidelines-recommended salvage therapy or is unable to
tolerate current therapy, and has persistent or recurrent disease in any of the
peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other site
lesions.
4. Expected survival time is more than 12 weeks;
5. ECOG 0-2 points (Appendix 2);
6. No serious mental disorders; The functions of important organs are basically normal:
1. Cardiac function: echocardiography indicated cardiac ejection fraction ≥50%, and no
obvious abnormality was found in electrocardiogram;
2. Renal function: serum creatinine ≤2.0×ULN;
3. Liver function: ALT and AST ≤ 3.0×ULN;
4. Total bilirubin and alkaline phosphatase ≤ 2.0×ULN (Gilbert syndrome ≤ 3.0×ULN);
5. Blood oxygen saturation > 92%.
7. The patient or his/her guardian agrees to participate in the clinical trial and
signs the ICF, indicating that he/she understands the purpose and procedure of
the clinical trial and is willing to participate in the study.
Exclusion Criteria:
1. Prior to screening, the following anti-tumor therapies were received: chemotherapy,
targeted therapy, or other investigational drug treatment within 14 days or at least
5 half-lives (whichever is shorter), except in cases where disease progression has
been confirmed after treatment;
2. had a cerebrovascular accident or seizure within 6 months before signing the ICF;
3. There is an active or uncontrolled infection that requires systemic treatment within
1 week prior to screening;
4. suffering from any of the following heart diseases:
1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;
2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6
months before enrollment;
3. A history of clinically significant ventricular arrhythmia, or unexplained
syncope (other than those caused by vasovagal or dehydration);
4. History of severe non-ischemic cardiomyopathy;
5. combined with active hepatitis B;
6. Combined with active autoimmune diseases, long-term immunosuppressive therapy is
required;
7. have other malignancies, except for adequately treated cervical carcinoma in situ,
basal cell or squamous cell skin cancer, local prostate cancer after radical
surgery, and ductal carcinoma in situ after radical surgery;
8. Had received live attenuated vaccine within 4 weeks prior to screening;
9. Women who are pregnant or breastfeeding, and male or female subjects who plan to
have a family within 1 year after receiving CAR T cell transfusion;
10. Circumstances deemed unsuitable for participation in the study by other researchers.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia Wei, MD
Start date:
August 31, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Chongqing Precision Biotech Co., Ltd
Agency class:
Industry
Collaborator:
Agency:
Shanxi Bethune Hospital
Agency class:
Other
Source:
Chongqing Precision Biotech Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06006403
