This single-arm, open-label pilot study will assess the safety and efficacy of RN1701, a bispecific CD19/CD20-targeted allogeneic CAR-T-cell product, in patients with relapsed or refractory B-cell lymphoma. Up to 19 participants will be enrolled in a conventional 3 + 3 dose-escalation scheme. The primary objective of the study is to evaluate the safety and feasibility of RN1701 for the treatment of relapsed/refractory B-cell lymphoma. The secondary objective is to evaluate the efficacy of RN1701 for the treatment of relapsed/refractory B-cell lymphoma. The exploratory objective is to evaluate the expansion, persistence, and ability of RN1701 to deplete CD19- and/or CD20-positive cells in patients with relapsed/refractory B-cell lymphoma.
Voluntary participation; full understanding of the study and provision of written informed consent obtained before any study-related procedure not part of standard care; willingness to comply with follow-up.
Age 18-75 years; either sex.
ECOG performance status 0-1.
Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and/or CD20 positive.
Malignancy that received curative therapy and has shown no evidence of active disease for ≥2 years before enrolment; or
Adequately treated non-melanoma skin cancer with no current evidence of disease.
CNS prophylaxis (e.g., intrathecal methotrexate and/or cytarabine) within 7 days;
Cytotoxic chemotherapy or radiotherapy within 14 days;
YANRU WANG
Lead sponsor
Affiliated Hospital of Jiangsu University
Sponsor institution
Allorunning Therapeutics
Collaborator