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RecruitingPhase 1NCT07164560

Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma

Clinical Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

45 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Refractory/Recurrent Peripheral T-cell Lymphoma

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria17

  • According to the 2016 WHO classification of lymphoid neoplasms, patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) must meet the following criteria to be eligible for enrollment:
  • Voluntarily agree to participate in this study and provide signed informed consent.
  • Age 18 to 75 years, male or female.
  • Diagnosis of relapsed/refractory PTCL, defined as failure of ≥1 prior line of therapy. Eligible histologic subtypes include (but are not limited to):
  • Angioimmunoblastic T-cell lymphoma (AITL) Anaplastic large cell lymphoma (ALCL) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
  • Estimated life expectancy ≥12 weeks.
  • TRBC1/2-positive tumor tissue (≥20% by immunohistochemistry) OR TCR gene rearrangement confirmed by PCR or NGS.
  • ECOG performance status of 0-2.
  • Adequate organ function as defined below:
  • 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
  • ≥3 months since prior autologous hematopoietic stem cell transplantation.
  • Prior CAR-NK therapy targeting a different antigen is permitted if lack of efficacy was confirmed after ≥3 months of evaluation, or if complete remission (CR) was achieved but relapse occurred.
  • Women of childbearing potential must have a negative pregnancy test prior to enrollment. All patients (male and female) must agree to use effective contraception during the study.
  • Presence of at least one measurable lesion.
  • All approved prior anti-tumor therapies (including systemic chemotherapy, total body irradiation, or immunotherapy) must have been completed ≥3 weeks before study drug administration; for non-chemotherapy targeted agents, a washout period of ≥2 weeks is required.

Exclusion Criteria14

  • Patients meeting any of the following criteria will be excluded from this study:
  • History of allergy to any component of the cell product.
  • History of another malignancy that has not achieved remission.
  • Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  • Receipt of gene therapy within the past 3 months.
  • Uncontrolled systemic active infection (with the exception of simple urinary tract infection or bacterial pharyngitis). Prophylactic use of antibiotics, antivirals, or antifungal agents is permitted.
  • Active hepatitis B infection (HBsAg positive; however, patients with HBV-DNA \<10³ copies/mL are not excluded), active hepatitis C virus infection (including carriers), syphilis, or other acquired or congenital immunodeficiency diseases, including but not limited to HIV infection.
  • New York Heart Association (NYHA) Class III or IV heart failure.
  • Unresolved toxicity from prior anti-tumor therapy (defined as CTCAE v5.0 Grade \>1, with the exception of fatigue, anorexia, and alopecia).
  • Evidence of central nervous system (CNS) involvement at screening, or clinically significant CNS disease such as a history of seizures or other CNS disorders.
  • Prior exposure to any agent specifically targeting TRBC1/2.
  • Lactating women who are unwilling to discontinue breastfeeding.
  • Any other condition that, in the opinion of the investigator, may increase patient risk or interfere with the study results.
  • People who test positive for COVID-19 or influenza A virus.

Interventions

BIOLOGICALAnti-TRBC1 CAR-T cells

Umbilical cord blood-derived NK cells transduced with lentiviral vector express anti-TRBC1 CAR

Locations(1)

2nd Affiliated Hospital,School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

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NCT07164560