A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Official Title

A Phase 1, Multicentre, Open-label Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Summary:

This is a Phase 1, first-in-human, open-label, multicentre study of CC-97540, CD19-targeted NEX-T chimeric antigen receptor (CAR) T cells, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-97540 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-97540 at the RP2D.

Trial Description

Primary Outcome:

• Adverse Events (AEs)

• Complete Response Rate (CRR)
• Overall response Rate (ORR)
• Duration of response (DOR)
• Time to response (TTR)
• Time to complete response (TTCR)
• Progression free survival (PFS)
• Overall survival (OS)
• Pharmacokinetics - peak expansion (Cmax)
• Pharmacokinetics -time to peak expansion (tmax)
• Pharmacokinetics - elimination half-life (t1/2)
• Pharmacokinetics - Area under curve (AUC)

View this trial on ClinicalTrials.gov