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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07164560 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplantation, solid organ transplantation, gene therapy disqualifies patients from enrollment.
Does this trial require TRBC1?
Yes, TRBC1 overexpression is a required biomarker for enrollment.
Does this trial require TRBC2?
Yes, TRBC2 overexpression is a required biomarker for enrollment.
Does this trial require TCR?
Yes, TCR gene rearrangement is a required biomarker for enrollment.
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 qualifyRelated pages