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.
1. 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.
2. Age 18-75 years; either sex.
3. ECOG performance status 0-1.
4. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and/or CD20 positive.
1. Any malignancy other than B-cell non-Hodgkin lymphoma ever diagnosed or treated, except: • 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.
2. Prior anti-cancer therapy within the stated windows (before lymphodepletion): • CNS prophylaxis (e.g., intrathecal methotrexate and/or cytarabine) within 7 days; • Cytotoxic chemotherapy or radiotherapy within 14 days; • Small-molecule targeted or epigenetic therapy within 14 days or 5 half-lives, whichever is longer; • Monoclonal antibody, bispecific antibody, or antibody-drug conjugate within 21 days or 5 half-lives, whichever is shorter; • Investigational drug or invasive investigational device within 28 days (if the therapy is also investigational, the 28-day wash-out applies); • Autologous haematopoietic stem-cell transplant or CD19-directed autologous CAR-T therapy within 100 days.
3. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.
4. Any allogeneic cellular (including CAR-T) or gene therapy.
Single group
RN1701 injection
Biological/VaccineRN1701 injection is a bispecific CD19/CD20-targeted allogeneic CAR-T. A single infusion of CAR-T cells will be administered intravenously
Toxicity and adverse event grading after RN1701 treatment
all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0
CRS grading after RN1701 treatment
CRS will be graded using the Lee DW et al. CRS grading scale. Grade 1: Fever, mild symptoms, manageable with supportive care Grade 2: Moderate symptoms (eg, hypotension, hypoxia), requires intervention (eg, intravenous fluids, antipyretics) Grade 3: Severe symptoms (eg, multiorgan involvement), requires corticosteroids and tocilizumab Grade 4: Life-threatening, requires intensive care unit (ICU) care and urgent interventions
Overall response rate (ORR =CR + PR) of patients receive RN1701 treatment
according to the Lugano criteria and CSCO guidelines
Disease control rate (DCR=CR +PR +SD) of patients receive RN1701 treatment
according to the Lugano criteria and CSCO guidelines
Assessment includes contrast enhanced CT of head/neck, chest, abdomen,and pelvis, plus whole-body PET-CT
Tumor measurements and evaluations must be performed with the same technique used at baseline
CAR copies of CAR-T in blood after RN1701 treatment
CAR copies in copies/ug genome DNA
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
