A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma
• The patient must be aware of and voluntarily sign the informed consent form (ICF).
• Aged between 18 and 70 years, both male and female.
• Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
• The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
• Relapsed/refractory DLBCL, FL, or MCL.
• At least one measurable or evaluable lesion.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Expected survival of ≥3 months.
• Adequate function of the heart, lungs, liver, kidneys, and other organs.