Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relap… (NCT07164560) | Clinical Trial Compass
RecruitingPhase 1
Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
China45 participantsStarted 2026-04-01
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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):
✓. 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:
✓. ≥3 months since prior autologous hematopoietic stem cell transplantation.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of dose limiting toxicity (DLTs)
Timeframe: Up to 28 days
Trial details
NCT IDNCT07164560
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. 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).