The Safety and Efficacy for Anti-human CLL-1 CAR-NK Cells in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is a single-arm, open-label, dose-escalation clinical trial aimed at exploring the safety, tolerability, and pharmacokinetic characteristics of the CLL-1 CAR NK cells, as well as providing preliminary observations on its efficacy in subjects with relapsed/refractory acute myeloid leukemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Age 18-70 years, gender unrestricted;

• Expected survival time exceeds 12 weeks;

• ECOG score 0-2;

• Meets the 2022 WHO criteria for acute myeloid leukemia and flow cytometry shows ≥70% expression of CLL1 in leukemia cells; or immunohistochemistry shows CLL1 expression ≥50% and meets the following criteria for relapse and refractory:

‣ Relapse criteria: Bone marrow shows primitive cells ≥5% after hematological remission (excluding post-chemotherapy hematopoietic recovery); or at least two peripheral blood samples taken at least one week apart show primitive cells; or extramedullary lesions are present. Early relapse (relapse within 12 months after initial remission) patients can be directly included, while late relapse (relapse after 12 months of initial remission) patients must have undergone salvage chemotherapy according to standard protocols without achieving complete remission. Salvage treatment for all relapsed patients should include at least one course of targeted therapy without achieving remission. Patients who relapse after allogeneic hematopoietic stem cell transplantation, have no other effective treatment options, and have no active grade 2 or higher acute GVHD.

⁃ Refractory criteria: No complete remission after two courses of standard intensive chemotherapy based on the 3+7 regimen, and no complete remission after second-line salvage chemotherapy or treatment including targeted therapy; or no complete remission after one course of purine analog induction chemotherapy (such as FLAG-Ida, CLIA, or similar regimens), and no complete remission after salvage treatment or treatment including targeted therapy; or no complete remission after three cycles of low-intensity treatment based on HMA, including low-intensity regimens containing venetoclax; relapse within 12 months after remission (early relapse); patients for whom the original induction is ineffective after relapse.

• Able to establish the required venous access for collection, and no contraindications for leukapheresis;

• Liver and kidney function, cardiac and pulmonary function meet the following requirements:

‣ Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min or creatinine ≤ 2.5×ULN;

⁃ Ejection fraction \>50%, no clinically significant electrocardiogram changes; baseline blood oxygen saturation \>92%; total bilirubin ≤ 3×ULN; ALT and AST ≤ 3×ULN;

• Able to understand and sign the informed consent form.

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 24
Treatments
Experimental: Anti CLL-1 CAR NK cells
Related Therapeutic Areas
Sponsors
Leads: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov