Clinical Study of TRBC1/2-Targeted CAR-T Cells in the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study aims to evaluate the safety and efficacy of TRBC1/2-directed chimeric antigen receptor T cells (TRBC1/2 CAR-T cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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‣ 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-T 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.

Locations
Other Locations
China
2nd Affiliated Hospital,School of Medicine,Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Wenbin Qian, professor
Qianwb@zju.edu.cn
87-57189713672
Backup
Xinbin Xiao, Doctor
xiaoxibinzju@zju.edu.cn
13858015535
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 45
Treatments
Experimental: PB TRBC1/2 CAR-T
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Ruijin Hospital, Peking University Cancer Hospital & Institute

This content was sourced from clinicaltrials.gov

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