OncoMatch/Clinical Trials/NCT06307054
CLL-1 CAR-NK Cells for Relapsed/Refractory AML
Is NCT06307054 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies anti-CLL-1 CAR NK cells for relapsed adult aml.
Treatment: anti-CLL-1 CAR NK cells — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A overexpression (≥70% by flow cytometry OR ≥50% by immunohistochemistry)
flow cytometry shows ≥70% expression of CLL1 in leukemia cells; or immunohistochemistry shows CLL1 expression ≥50%
Excluded: PML fusion with RARA
Confirmed AML with PML-RARA fusion gene
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: targeted therapy — relapsed
Salvage treatment for all relapsed patients should include at least one course of targeted therapy without achieving remission
Must have received: standard intensive chemotherapy (3+7 regimen) — refractory
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
Must have received: purine analog induction chemotherapy (FLAG-Ida, CLIA) — refractory
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
Must have received: low-intensity treatment based on HMA (including venetoclax) (venetoclax) — refractory
no complete remission after three cycles of low-intensity treatment based on HMA, including low-intensity regimens containing venetoclax
Cannot have received: CAR-T therapy or other gene-modified cell therapy
Subjects who have received CAR-T therapy or other gene-modified cell therapy in the past
Lab requirements
Kidney function
creatinine clearance ≥ 60 ml/min or creatinine ≤ 2.5×uln
Liver function
total bilirubin ≤ 3×uln; alt and ast ≤ 3×uln
Cardiac function
ejection fraction >50%, no clinically significant electrocardiogram changes
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06307054 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T therapy or other gene-modified cell therapy disqualifies patients from enrollment.
Does this trial require CLEC12A?
Yes, CLEC12A overexpression is a required biomarker for enrollment.
Are patients with PML alterations eligible?
No. PML fusion with RARA is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages