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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06909474 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-NK therapy or genetically modified cell therapy disqualifies patients from enrollment.
Does this trial require CD5?
Yes, 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) is a required biomarker for enrollment.
What disease stage is eligible?
Stage STAGE IIB OR HIGHER (FOR MF/SS) is required.
Is there an age limit?
Yes. Patients must be 75 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 qualify