- |||||||||| ASC-618 / ASC Therapeutics
Enrollment open, Gene therapy: ASC618 Gene Therapy in Hemophilia A Patients (clinicaltrials.gov) - Aug 19, 2022
P1/2, N=12, Recruiting,
The potency of ASC618 GMP lots relative to that of a reference standard (ASC618 Engineering Lot), which is evaluated by two assays that we have developed: a Potency-ELISA assay and a Potency-Activity assay, which XYNTHA Not yet recruiting --> Recruiting
- |||||||||| ASC930 / Applied StemCell, City of Hope, Karolinska Institute, Stanford University
Essential Biomarkers for a Clinical Study of a Novel Allogeneic Cell Therapy for Acute Graft-versus-Host Disease (ExCel Center, ICC Capital Suite Room 1) - May 13, 2022 - Abstract #ISTH2022ISTH_2485;
P2
These results are being assessed in vivo with the methodology described above, focusing on DSC pharmacokinetics and pharmacodynamics, as well as immune and therapeutic response. Conclusion(s): The introduction of selective biomarkers of cellular, immune, and disease response to DSCs can help select the right patient, the right treatment, and the right monitoring in the treatment of aGVHD.
- |||||||||| ASC-618 / Applied StemCell, Expression Therap
Clinical Study of Adenovirus-Associated Viral Vector-Mediated Gene Therapy of Human Factor VIII in Severe and Moderately Severe Hemophilia A (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1061;
P1/2
Preclinical work demonstrated that in the C57Bl/6 murine model, the cynomolgus monkey, and the humanized liver mouse model (FRG-KO), ASC618 was well tolerated at all doses evaluated with no toxicologically significant microscopic findings (Veselinovic 2020). Conclusion(s): ASC618 will be evaluated in this clinical program for its potential to provide durable therapeutic benefit, reduce treatment burden on patients and significantly improve their quality of life.
- |||||||||| ASC-618 / Applied StemCell, Expression Therap
Pharmacology, Toxicology and Safety Studies of ASC618, a Second Generation Factor VIII Gene Therapy for Hemophilia A (Poster Board Number: Tu-288; Hall D) - Apr 20, 2022 - Abstract #ASGCT2022ASGCT_1238;
P1/2
The no-observed-effect level (NOEL) has also not been established since the lowest tested dose 2E11 was found to be efficacious. Based on these results and dose translation approach the program received IND clearance from the U.S. FDA and a phase 1/2 clinical trial to evaluate the safety, tolerability, and preliminary efficacy of ASC618 (NCT04676048) will be conducted.
- |||||||||| ASC-618 / ASC Therapeutics
Trial completion date, Trial initiation date, Trial primary completion date, Gene therapy: ASC618 Gene Therapy in Hemophilia A Patients (clinicaltrials.gov) - Nov 18, 2021
P1/2, N=12, Not yet recruiting,
This approach was presented in the ASC618 IND submission and the program received IND clearance from the U.S. FDA and a phase 1/2 clinical trial to evaluate the safety, tolerability, and preliminary efficacy of ASC618 (NCT04676048) will be conducted. Trial completion date: Jul 2026 --> Dec 2026 | Initiation date: Jul 2021 --> Apr 2022 | Trial primary completion date: Jul 2023 --> Dec 2023
- |||||||||| ASC930 / ASC Therapeutics, City of Hope, Karolinska Institute, Stanford University
Trial completion date, Trial initiation date, Trial primary completion date: ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) (clinicaltrials.gov) - Nov 18, 2021
P2, N=60, Not yet recruiting,
Trial completion date: Jul 2026 --> Dec 2026 | Initiation date: Jul 2021 --> Apr 2022 | Trial primary completion date: Jul 2023 --> Dec 2023 Trial completion date: Mar 2023 --> Sep 2023 | Initiation date: Sep 2021 --> Jul 2022 | Trial primary completion date: Sep 2022 --> Sep 2023
- |||||||||| ASC-618 / ASC Therapeutics
Trial completion date, Trial initiation date, Trial primary completion date, Gene therapy: ASC618 Gene Therapy in Hemophilia A Patients (clinicaltrials.gov) - May 12, 2021
P1/2, N=12, Not yet recruiting,
Trial completion date: Mar 2023 --> Sep 2023 | Initiation date: Sep 2021 --> Jul 2022 | Trial primary completion date: Sep 2022 --> Sep 2023 Trial completion date: Apr 2026 --> Jul 2026 | Initiation date: Apr 2021 --> Jul 2021 | Trial primary completion date: Apr 2026 --> Jul 2023
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