NCT07164560

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a multicenter, open-label, single-arm, phase I clinical trial designed to evaluate the safety and efficacy of TRBC1/2 CAR-NK cell therapy in patients with TRBC1/2-positive T-cell lymphoma. The study will be conducted in two parts: Phase I (Dose Escalation): A dose-escalation study will be carried out following the conventional "3+3" design, with one dose level administered via intravenous infusion. Each cohort will enroll 3 to 6 patients. After the initial infusion, patients will be observed for at least 28 days for safety evaluation, followed by long-term follow-up of up to 2 years post-infusion. Phase II (Dose Expansion): Based on safety, in vivo expansion and persistence of TRBC1/2 CAR-NK cells, and preliminary efficacy results from Phase I, the recommended dose and administration schedule will be determined. Approximately 30 eligible patients will then be enrolled to further assess safety and efficacy at the selected dose. Following the first infusion of TRBC1/2 CAR-NK cells, patients will continue in long-term follow-up for up to 2 years.

Conditions

• Refractory/Recurrent Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Anti-TRBC1 CAR-T cells	Umbilical cord blood-derived NK cells transduced with lentiviral vector express anti-TRBC1 CAR

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-01-01
• Completion: 2029-04-01
• First posted: 2025-09-10
• Last updated: 2026-03-17

Locations

1 site across 1 country: China