OncoMatch/Clinical Trials/NCT06909474
Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies
Is NCT06909474 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Anti-CD5 CAR NK cells for t-all/lymphoma.
Treatment: Anti-CD5 CAR NK cells — This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD5 positivity (≥80% tumor cells express CD5 with MFI equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) (≥80% (flow cytometry), Dim ≥1 log lower, partial 20-80%; or >30% (IHC))
CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity [MFI] equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) or immunohistochemistry (>30% tumor cells express CD5)
Disease stage
Required: Stage STAGE IIB OR HIGHER (FOR MF/SS)
At least one bidimensionally measurable lesion per Lugano 2014 criteria: nodal lesions >1.5 cm in long axis; extranodal lesions >1.0 cm in long axis
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy
Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR); Relapsed within 12 months after achieving CR with first-line induction therapy; Failure to achieve CR or relapse after ≥2 lines of chemotherapy; Relapse after hematopoietic stem cell transplantation (HSCT); Refractory to ≥2 lines of chemotherapy, primary resistance, or relapse post-HSCT
Cannot have received: CAR-NK therapy or genetically modified cell therapy
Prior CAR-NK therapy or genetically modified cell therapy
Lab requirements
Kidney function
serum creatinine ≤2.0×uln
Liver function
alt/ast ≤3.0×uln (≤5.0×uln if liver involvement); total bilirubin ≤2.0×uln
Cardiac function
left ventricular ejection fraction (lvef) ≥50% by echocardiography; no significant ecg abnormalities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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