EVEREST-1: A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530 an Autologous Logic-gated Tmod CAR T in Heterozygous HLA-A*02 Adults with Recurrent Unresectable Locally Advanced or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression
Brief description of study
This is a first-in-human, seamless Phase 1/2, multicenter, open-label, nonrandomized study. This study consists of Phase 1 dose-escalation and dose-expansion portions and a Phase 2 cohort-expansion portion.The primary objectives of Phase 1 are to evaluate the safety and tolerability of A2B530, and to determine the recommended Phase 2 dose (RP2D).The primary objective of Phase 2 is to evaluate the efficacy of A2B530.
Clinical Study Identifier: s23-00280
ClinicalTrials.gov Identifier: NCT05736731
Principal Investigator:
Salman Rafi Punekar.
Other Investigators:
Nila Theresa De La Rosa,
Jaime Andres Suarez Londono,
Nicole Karich,
Elaine Shum,
Rena Kandinova,
Scot Niglio,
Jamie M Pavlonnis,
Eneil De La Pena,
Marissa Hornacek,
Kirby Rodriguez,
Mohammad Maher Abdul Hay,
Amanda Marie Ferris,
Oscar B Lahoud,
Jingmei Hsu,
Joshua K Sabari,
Anna C Hatzinikolaou,
Nina Beri,
Caitlin Elizabeth Ryan,
Eileen Zhao,
Julia M Buchheit,
Jessica Wang,
Maureen E Musatto,
Kelsey Stocker,
Sejal Singh,
Laura P. Diaz,
Samantha VanMaanen,
Keriann M Scavone,
Kristen Randolph Jordan,
Rafael C Singson,
Jamie Robin Nemrow,
Kristen Spencer,
Chelsea F Curione,
Kathleen M Madden,
Nancy Chan,
Taylor Patricia Harrington,
Douglas K Marks.
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