Promising anti-tumor activity reported for C-CAR031, a
novel Glypican 3 (GPC3)-targeting cell therapy designed by
AstraZeneca
SHANGHAI, April 17, 2023 /PRNewswire/ -- Shanghai
Cellular Biopharmaceutical Group Ltd. (the Company, or Shanghai
Cellular Bio), a company engaged in the drug development of
immunotherapies for cancer and stem cell therapies for degenerative
diseases, today presented data from the First-in-Human (FIH) Phase
I trial evaluating C-CAR031 at the 2023 American Association for
Cancer Research (AACR) Annual Meeting.
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 AstraZeneca
(LSE/STO/Nasdaq:AZN) using their TGFβRII dominant negative armoring
discovery platform.
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 The First Affiliated Hospital, Zhejiang
University School of Medicine in Hangzhou, China.
Poster
Title:
|
"First report of
preliminary safety, efficacy, and pharmacokinetics of
C-CAR031 (GPC3-specific TGFβRIIDN CAR-T) in patients with advanced
HCC"
|
Session:
|
Session PO.CT01.01 -
First-in-Human Phase I Clinical Trials 1
|
Poster No:
|
CT097
|
Date:
|
Monday, April 17,
2023
|
Time:
|
1:30 pm to 5:00 p.m.
EDT
|
Location:
|
Orange County
Convention Center in Orlando, Florida
|
|
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 March
2nd, 2023, seven patients received two dose
levels (DL1, n=1; DL2, n=6) of C-CAR031. The median number of prior
lines of therapies was 4 (range 1-6). The median follow-up was 77
(67-213) days. Seven patients with ≥28 days' follow-up were
eligible for safety evaluation. Good safety profile was observed at
explored dose levels. 86% (6/7) patients experienced Gr1/2
CRS; no Dose Limiting Toxicities (DLT) or ICANS was observed. The
≥Gr3 non-hematologic product-related AE included transient Gr3 AST
elevation (2/7, 28%), hypokalemia (1/7, 14%), and abdominal pain
(1/7,14%). 5/6 (83%) patients at DL2 showed tumor shrinkage post
C-CAR031 treatment (median -41.4% range -3.4%~ - 94.4%). Best
clinical responses at DL2 included 3 confirmed PR, 2 SD and 1 PD
per both RECIST v1.1 and mRECIST. The clinical responses of the
patients who achieved PR are ongoing up to the cutoff date.
C-CAR031 showed a robust cellular kinetic profile. CAR-T cells were
detectable in blood of all patients in the last follow-up.
Conclusion: In this FIH study, C-CAR031 is well tolerated
and shows promising anti-tumor activity. Enrollment is ongoing to
confirm initial results.
About Shanghai Cellular Biopharmaceutical
Group Ltd
Shanghai Cellular Biopharmaceutical Group Ltd develops
proprietary cell therapies for the treatment of cancerous diseases
and autoimmune diseases, and operates state-of-the-art research and
GMP facility in Shanghai,
China. Shanghai Cellular Bio partners with its
affiliate in Maryland to augment
its global research and development capabilities. Shanghai Cellular
Bio and its affiliate conduct multiple clinical studies comprised
of C-CAR039 Phase 1b trial,
C-CAR066 targeting treatment for r/r NHL, C-CAR088, an
autologous anti-B cell maturation antigen (BCMA) CAR-T for r/r
myeloma (MM), C-CAR031, an autologous armored anti-GPC3 CAR-T for
Hepatocellular carcinoma (HCC), C-TIL051, an autologous
tumor-infiltrating lymphocytes (TIL) therapy for non-small cell
lung cancer (NSCLC); and continue to discover and develop
multiple novel T cell therapies for solid tumor and for orphan
autoimmune diseases.
Company Contact:
Sarah
Kelly
Communications & Investor Relations
Shanghai Cellular Biopharmaceutical Group Ltd.
Phone: +86 21 5406 9990
Email: s.kelly@shcellbio.com
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