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Clinical Trial Summary

This is a Phase 1, first-in-human, open-label, multicenter 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04231747
Study type Interventional
Source Juno Therapeutics, a Subsidiary of Celgene
Contact
Status Completed
Phase Phase 1
Start date May 21, 2020
Completion date February 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT02342665 - Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL Phase 1/Phase 2