SUZHOU, China,
May 23,
2024 /PRNewswire/ -- On May
10, 2024, Cure Genetics announced the safety and efficacy
data of their CAR-NKT product, CGC729, for patients with relapsed
and refractory metastatic renal cell carcinoma (R/R mRCC) in an
oral presentation at the 27th Annual Meeting of the American
Society for Gene & Cell Therapy (ASGCT) in Baltimore. This marked the first-in-human
trial using CAR-NKT therapy for R/R mRCC, demonstrating a good
safety profile and encouraging anti-tumor activity.
This phase I dose-escalation clinical trial was conducted at
Fudan University Shanghai Cancer Center using a single-arm, 3+3
design to evaluate the safety and efficacy of CGC729 at three
dose levels (DL1: 5 x 106/m2; DL2: 1.5 x
107/m2; DL3: 4.5 x
107/m2) in the treatment of R/R mRCC patients
who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and
received a single infusion of CGC729. All patients underwent
lymphodepletion prior to CGC729 infusion.
Safety Evaluation: As of April 11, 2024, all five patients (three in DL1
and two in DL2) experienced no dose-limiting toxicities
(DLTs). The most common adverse events were lymphodepletion-related
neutropenia, thrombocytopenia, and leukopenia. One patient in DL1
(0102) developed grade 2 cytokine release syndrome (CRS), which
resolved within 24 hours; the same patient also developed grade 2
immune effector cell-associated neurotoxicity syndrome (ICANS),
which improved rapidly after symptomatic treatment.
Efficacy Evaluation: Among four eligible patients,
the overall response rate (ORR) reached 50% (2/4). Among
CD70 positive patients (n=3),ORR was 66.7% (2/3), with two
patients achieving partial response (PR). CGC729 demonstrated
promising efficacy with deep anti-tumor activity. The longest
duration of response (DOR) is continuing at nine-month after
treatment. Furthermore, pharmacokinetic measurements showed robust
expansion of CGC729 in all subjects, regardless of the CD70
expression level in the tumor, with prolonged persistence in the
blood up to 20 weeks.
Conclusion: The interim analysis of this first-in-human
trial shows that anti-CD70 CAR-NKT (CGC729) has a good safety
profile and robust anti-tumor activity. It may provide a promising
treatment option for R/R mRCC in the future.
About the ASGCT Presentation
Title:Interim Safety and Efficacy Evaluation of Anti-CD70
CAR-NKT (CGC729) Phase I Study for Patients with Relapsed and
Refractory Metastatic Renal Cell Carcinoma (R/R mRCC)
No:Late-breaking Abstract No. 10
Format:Oral presentation
Room:Ballroom 4
Time:2024/5/10 8:30 am - 8:45
am
Presenter:Dr. Yuanyuan
Qu, Fudan Univeristy Shanghai Cancer Center
About AIMS CAR-NKT
The challenge of treating solid tumors is compounded by tumor
heterogeneity and a suppressive tumor microenvironment (TME), which
are major barriers to successful CAR-T cell therapy. Addressing
this, Natural Killer T (NKT) cells, a subset of multifactorial
innate-like T cells, offer new possibilities in solid tumor therapy
due to their multifactorial anti-tumor capabilities and TME
modulation properties.
Cure Genetics' innovative AIMS CAR-NKT platform is based on
these NKT cell features, aimed at enhancing solid tumor
infiltration, modulating the TME, and prolonging sustained
expansion. This platform has demonstrated good safety and promising
efficacy in our lead product, CGC729, and is concurrently being
expanded to other autologous/allogeneic products.
About CGC729
CGC729 is an autologous anti-CD70 CAR-NKT with a differentiated
mechanism of action from T cells and NK cells. First, CGC729
combines adaptive and innate immunity with multiple tumor-killing
mechanisms targeting CD70, CD1d, and stress ligands frequently
expressed in RCC. Additionally, CGC729 has the capability to
modulate the TME through skewing macrophage differentiation and
resisting TGF-β inhibition.
About Cure Genetics
Cure Genetics, established in Suzhou in 2016, is a
clinical-stage company dedicated to developing cell and gene
therapies for solid tumors and genetic diseases. Through the
innovative AIMS CAR-NKT and VELP™ AAV platforms, Cure Genetics has
developed a differentiated pipeline. By leveraging global
collaborations and out-license, we actively drive the research and
development, and commercialization of innovative drugs. We aim to
provide effective treatment measures for patients worldwide with
unmet medical needs and to become a benchmark in the global field
of cell and gene therapy.
Media Enquiry: bd@curegenetics.com
View original
content:https://www.prnewswire.com/news-releases/cure-genetics-announced-promising-safety-and-efficacy-data-of-car-nkt-product-cgc729-for-rcc-at-asgct-2024-302153612.html
SOURCE Cure Genetics