OncoMatch/Clinical Trials/NCT07164560
Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
Is NCT07164560 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Anti-TRBC1 CAR-T cells for refractory/recurrent peripheral t-cell lymphoma.
Treatment: Anti-TRBC1 CAR-T cells — This study aims to evaluate the safety and efficacy of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 (TRBC1/2 CAR-NK cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: TRBC1 overexpression (≥20% by immunohistochemistry)
TRBC1/2-positive tumor tissue (≥20% by immunohistochemistry)
Required: TRBC2 overexpression (≥20% by immunohistochemistry)
TRBC1/2-positive tumor tissue (≥20% by immunohistochemistry)
Required: TCR gene rearrangement
TCR gene rearrangement confirmed by PCR or NGS
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Prior allogeneic hematopoietic stem cell transplantation
Cannot have received: solid organ transplantation
Prior solid organ transplantation
Cannot have received: gene therapy
Receipt of gene therapy within the past 3 months
Cannot have received: CAR-NK therapy targeting TRBC1/2
Prior exposure to any agent specifically targeting TRBC1/2
Lab requirements
Blood counts
Phase Ia: ANC > 1500/mm³, platelets > 75 × 10⁹/L, hemoglobin > 9 g/dL; Phase Ib: ANC > 1000/mm³, platelets > 50 × 10⁹/L, hemoglobin > 8 g/dL
Kidney function
Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min
Liver function
ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
ALT and AST ≤ 2.5 × upper limit of normal (ULN) Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min Total bilirubin ≤ 1.5 × ULN Left ventricular ejection fraction (LVEF) ≥ 50% Baseline oxygen saturation > 92% on room air Hematology: Phase Ia: ANC > 1500/mm³, platelets > 75 × 10⁹/L, hemoglobin > 9 g/dL Phase Ib: ANC > 1000/mm³, platelets > 50 × 10⁹/L, hemoglobin > 8 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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