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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

Excerpt:
...Phase Ib:Tumor tissue samples were positive for CLDN18.2 IHC staining; Phase II:Tumor tissue samples were positive for CLDN18.2 IHC staining and HER2 expression was negative; 5....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Safety, tolerability, and preliminary efficacy results in patients with advanced gastric/gastroesophageal junction adenocarcinoma from a phase Ib/II study of CLDN18.2 CAR T-cell therapy (CT041).

Published date:
05/26/2022
Excerpt:
...the safety, tolerability and efficacy of CT041 in patients with previously treated, CLDN18.2-positive advanced G/GEJ cancer...As of the data cut-off, 8 of 14 (57.1%) patients achieved partial response (PR); 2 of 14 (14.3%) patients showed stable disease (SD). With a median follow-up time of 8.9 months (95%CI 5.91, NE), the median progression-free survival (PFS) was 5.6 months (95%CI 1.9, 7.4), and median overall survival (OS) was 10.8 months (95%CI 5.1, NE) with 7 patients still alive at last follow-up....These preliminary results suggest that CT041 had manageable safety/tolerability profile and promising efficacy in patients with previously treated advanced G/GEJ cancer.
DOI:
10.1200/JCO.2022.40.16_suppl.4017
Trial ID: