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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.

Phase 1RecruitingSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT07164560Data as of May 2026

Treatment: Anti-TRBC1 CAR-T cellsThis 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).

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Extracted 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

Min 1 prior line

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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