Shanghai Cellular Biopharmaceutical Group presents first data from Phase I trial evaluating a novel CAR-T in advanced liver cancer at AACR Annual Meeting
Shanghai Cellular Biopharmaceutical Group Ltd. presented promising results for C-CAR031, a novel cell therapy targeting Glypican 3 (GPC3), at the AACR Annual Meeting on April 17, 2023. The Phase I trial indicated that C-CAR031 is well tolerated, showing objective responses in patients with advanced hepatocellular carcinoma (HCC). Out of seven patients, three achieved confirmed partial responses, with substantial tumor shrinkage observed (median -41.4%). The therapy employs a unique safety-enhancing design and aims to provide an effective treatment option for HCC. Ongoing enrollment efforts seek to further confirm these initial findings.
- C-CAR031 shows promising anti-tumor activity in early Phase I trial.
- Three patients achieved confirmed partial responses with ongoing clinical evaluations.
- Median tumor shrinkage of 41.4% observed in patients treated with C-CAR031.
- The therapy reported a good safety profile with no Dose Limiting Toxicities.
- Enrollment ongoing to confirm initial trial results.
- One patient experienced progressive disease, indicating potential limitations of the therapy.
Promising anti-tumor activity reported for C-CAR031, a novel Glypican 3 (GPC3)-targeting cell therapy designed by
Early results indicate that C-CAR031 is well tolerated with promising anti-tumor activity seen and objective responses in several patients to date, including 3 patients with confirmed partial responses, 2 with stable disease and 1 with progressive disease per both RECIST v1.1 and mRECIST criteria. The clinical responses of the patients who achieved partial responses are ongoing up to the data cutoff date.
C-CAR031 is an autologous GPC3-directed second generation armored CAR-T with affinity-tuned single-chain variable fragment (scFv) to enhance its safety profile, based on a novel cell therapy designed by
To investigate the feasibility, safety and initial efficacy of C-CAR301 in hepatocellular carcinoma (HCC), Shanghai Cellular Bio is currently conducting a Phase I FIH clinical study (NCT05155189) in advanced HCC in
Poster Title: | "First report of preliminary safety, efficacy, and pharmacokinetics of |
Session: | Session PO.CT01.01 - First-in-Human Phase I Clinical Trials 1 |
Poster No: | CT097 |
Date: | |
Time: | |
Location: | |
Exhibit Halls Poster Section 45, Poster Board Number 5 | |
Website: | https://www.abstractsonline.com/pp8/#!/10828/presentation/10293 |
Methods: This FIH, open-label dose escalation trial employs an accelerated dose titration plus i3+3 design. Histologically confirmed GPC3+ advanced HCC patients (pts) who failed systemic treatments received a single-dose i.v. infusion of C-CAR031 following standard lymphodepletion. The primary objective was to assess the safety and tolerability. Adverse events (AEs) were graded using CTCAE 5.0, and cytokine release syndrome (CRS) / immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to ASTCT 2019 criteria.
Results: As of
Conclusion: In this FIH study, C-CAR031 is well tolerated and shows promising anti-tumor activity. Enrollment is ongoing to confirm initial results.
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