SHANGHAI, Aug. 19,
2024 /PRNewswire/ -- CARsgen Therapeutics Holdings
Limited (Stock Code: 2171.HK), a company focused on innovative CAR
T-cell therapies for the treatment of hematologic malignancies and
solid tumors, announces that the completion of enrollment in the
pivotal Phase II clinical trial of satricabtagene autoleucel
("satri-cel", R&D code: CT041, an autologous CAR-T product
candidate against Claudin18.2) in accordance with the clinical
protocol, for advanced gastric/gastroesophageal junction cancers
(GC/GEJ) in China.
This study is an open-label, multicenter, randomized clinical
trial in China evaluating the
efficacy and safety of satri-cel in subjects with
Claudin18.2-positive advanced GC/GEJ patients who have failed at
least two prior lines of therapy. Treatment for the control group
is physician's choice (paclitaxel, docetaxel, irinotecan, apatinib,
or nivolumab).
Gastric cancer is one of the most common malignant tumors in
China, with an incidence of
approximately 359,000 incident cases and a mortality of
approximately 260,000 deaths in 2022[1]. Patients with
advanced gastric cancer often face limited treatment options and
poor prognosis. There is a strong need for more innovative and
efficacious therapies. Satri-cel is an autologous CAR T-cell
product candidate against Claudin18.2 that has the potential to be
first-in-class globally. It primarily targets GC/GEJ and pancreatic
cancer (PC). The published clinical data on satri-cel have shown
promising safety and efficacy.
The final results of the investigator-initiated Phase I clinical
trial CT041-CG4006 (NCT03874897) were published in Nature
Medicine and orally presented at the 2024 ASCO annual meeting.
There were no dose-limiting toxicities (DLTs), no Grade 3 or higher
cytokine release syndrome (CRS), or immune effector cell-associated
neurotoxicity syndrome (ICANS) observed. In 51 patients with GC/GEJ
with target lesions at baseline who received satri-cel monotherapy,
the overall response rate (ORR) was 54.9% (28/51), the disease
control rate (DCR) was 96.1% (49/51), and the median duration of
response (mDOR) was 6.4 months.[2][3] The phase Ib
results from CT041-ST-01 (NCT04581473) clinical trial presented at
the 2022 ASCO annual meeting, further showed the manageable safety
and promising efficacy of satri-cel. Among 14 GC/GEJ patients who
had received at least 2 prior lines of treatment and received
satri-cel monotherapy, there were no DLTs or AEs leading to death.
No ICANS or gastrointestinal mucosal injury were reported. The ORR
and DCR were 57.1% and 78.6% respectively.[4]
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive
Officer, and Chief Scientific Officer of CARsgen Therapeutics,
said, "We are very pleased to announce the successful completion of
patient enrollment in the pivotal Phase II clinical trial of
satri-cel in China. This
significant milestone marks another solid step forward in our
development of CAR T-cell therapies for solid tumors. We extend our
gratitude to all the investigators, the patients and their families
for their trust and support. We look forward to the submission of
New Drug Application and the approval in China, to benefit patients with gastric
cancer. As one of the leading companies in the field of CAR T-cell
therapies, we remain committed to addressing the major challenges
faced by existing CAR T-cell therapies and will develop more
innovative CAR-T products for cancer patients."
About Satri-cel
Satri-cel is an autologous CAR T-cell product candidate against
the protein Claudin18.2 that has the potential to be first-in-class
globally. Satri-cel targets Claudin18.2 positive solid tumors with
a primary focus on gastric cancer/gastroesophageal junction cancer
(GC/GEJ) and pancreatic cancer (PC). Ongoing trials include
investigator-initiated trials (CT041-CG4006, NCT03874897), a
confirmatory Phase II clinical trial for advanced GC/GEJ in
China (CT041-ST-01, NCT04581473),
a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase
1b/2 clinical trial for advanced
gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595).
Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT)
designation by the U.S. FDA for the treatment of
Claudin18.2-positive advanced GC/GEJ cancers in January 2022 and PRIME eligibility by the EMA for
the treatment of advanced gastric cancer in November 2021. Satri-cel received an Orphan Drug
designation from the U.S. FDA in 2020 for the treatment of GC/GEJ
and an Orphan Medicinal Product designation from the EMA in 2021
for the treatment of advanced gastric cancer.
About CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company with operations in
China and the U.S., focusing on
innovative CAR T-cell therapies for the treatment of hematologic
malignancies and solid tumors. CARsgen has established a
comprehensive CAR T-cell research and development platform that
covers target discovery, innovative CAR T-cell development,
clinical trials, and commercial-scale production. Internally,
CARsgen has developed novel technologies and a product pipeline
with global rights to address significant challenges faced by
existing CAR T-cell therapies. Efforts include improving safety
profile, enhancing the efficacy in treating solid tumors, and
reducing treatment costs. CARsgen's mission is to become a global
biopharmaceutical leader that provides innovative and
differentiated cell therapies for cancer patients worldwide and
makes cancer curable.
Forward-looking Statements
All statements in this press release that are not historical
fact or that do not relate to present facts or current conditions
are forward-looking statements. Such forward-looking statements
express the Group's current views, projections, beliefs and
expectations with respect to future events as of the date of this
press release. Such forward-looking statements are based on a
number of assumptions and factors beyond the Group's control. As a
result, they are subject to significant risks and uncertainties,
and actual events or results may differ materially from these
forward-looking statements and the forward-looking events discussed
in this press release might not occur. Such risks and uncertainties
include, but are not limited to, those detailed under the heading
"Principal Risks and Uncertainties" in our most recent annual
report and interim report and other announcements and reports made
available on our corporate website, https://www.carsgen.com. No
representation or warranty is given as to the achievement or
reasonableness of, and no reliance should be placed on, any
projections, targets, estimates or forecasts contained in this
press release.
References
[1] Han B, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024
Feb 2;4(1):47-53. doi:
10.1016/j.jncc.2024.01.006
[2] Qi C, et al. Claudin18.2-specific CAR T cells in
gastrointestinal cancers: phase 1 trial final results. Nat
Med. 2024 Jun 3. doi:
10.1038/s41591-024-03037-z
[3] Qi C, et al. 2024 ASCO Abstract #2501
[4] Qi C, et al. 2022 ASCO Abstract #4017
View original content to download
multimedia:https://www.prnewswire.com/news-releases/carsgen-announces-enrollment-completion-in-china-gcgej-pivotal-phase-ii-clinical-trial-of-the-first-in-class-claudin18-2-car-t-satri-cel-302225000.html
SOURCE CARsgen Therapeutics