A Phase Ib/II Exploratory Clinical Trial of Memory-Enhanced 7×19-THEMIS CAR-T Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma: A Single-Arm Design Using a Historical Control (7×19 CAR-T)
This study is aimed to explored the safety and efficacy of 7×19-THEMIS CAR-T cell therapy for large B-cell lymphoma and to conduct an exploratory comparison of the 3-month objective response rate (ORR) and complete remission rate (CR rate) between the experimental cohort and the historical control cohort (NCT04833504).
• Voluntarily participate in this study and sign the informed consent form.
• Age range: 18 - 75 years old. Gender is not restricted.
• Histologically confirmed large B-cell lymphoma, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL), and mantle cell lymphoma (MCL).
• CD19-positive (as determined by immunohistochemistry or flow cytometry; based on the most recent tumor biopsy results).
• Definition of relapsed/refractory: Failure to achieve complete remission (CR) after at least two lines of therapy (which must include a CD20 monoclonal antibody and an anthracycline); or disease progression during any course of treatment; or relapse/progression within 12 months after autologous hematopoietic stem cell transplantation.
• At least one measurable lesion: any lymph node lesion with a longest dimension \>1.5 cm, or any extranodal lesion with a longest dimension \>1.0 cm, and the lesion shows uptake on PET-CT (SUV greater than the hepatic pool).
• Absolute neutrophil count in peripheral blood ≥ 1,000/μL; platelet count ≥ 45,000/μL.
• Cardiac, hepatic, and renal function: creatinine \< 1.5 mg/dL; ALT/AST ≤ 2.5 times the upper limit of normal; total bilirubin \< 1.5 mg/dL; ejection fraction ≥ 50%.
• Possess sufficient cognitive capacity to voluntarily sign the informed consent form.
⁃ Participants of reproductive potential must be willing to use effective contraception (from the time of signing the informed consent form until 12 months after CAR-T infusion).
⁃ The investigator estimates a life expectancy of at least 4 months.
⁃ Willing to comply with the schedule of visits, dosing regimen, laboratory tests, and other trial procedures.