This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (PiNACLE-H2H)
A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting
Diffuse large B-cell lymphoma
All genders
18+
Recruiting now
Overview
Principal Investigator: Nadia Khan
Contact Us
Latoya Marshall
Study details
Inclusion Criteria
- CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
- Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
-Diffuse large B-cell lymphoma (DLBCL)
-Transformations of indolent B-cell lymphomas (excluding Richter's transformation)
-DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
-High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)
-Primary mediastinal large B-cell lymphoma (PMBCL)
-Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B) - Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy
Exclusion Criteria
- Patients ineligible to receive CD19 CAR T-cell therapy
- Primary CNS lymphoma
- Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation)
Study Requirements
Patients will be randomized (1:1) before leukapheresis to receive either Ronde-cel or
Investigator's choice of axi-cel or liso-ce. Approximately 400 participants will be enrolled. CAR T-cell therapy in both arms will be administered as a single intravenous infusion following fludarabine and cyclophosphamide lymphodepletion. Participants will be followed for 3 years for safety and efficacy, with long-term follow-up extending to 15 years.