drugset / Trial / NCT03960840

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

NCT03960840

Phase 1/2 Active not recruiting 217 enrolled Novartis Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).

Timeline

Start
2019-06-26
Primary completion
2027-06-30
Completion
2028-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject rapcabtagene autoleucel Cell therapy
Background Ibrutinib Small molecule Oral