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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Umbilical cord blood-derived NK cells transduced with lentiviral vector express anti-TRBC1 CAR
2nd Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGIncidence of dose limiting toxicity (DLTs)
To evaluate the safety, tolerability, and determine the recommended dosage of peripheral blood-derived Anti-TRBC1/2 CAR-T Cell Therapy for refractory/relapsed peripheral T-cell lymphoma.
Time frame: Up to 28 days
Complete response rate (CR)
To determine the anti-tumor effectivity of PB TRBC1/2 CAR-T
Time frame: 3 months
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