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