Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases
Launched by PERSONGEN BIOTHERAPEUTICS (SUZHOU) CO., LTD. · Mar 11, 2025
Trial Information
Current as of April 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
Subjects who meet the inclusion/exclusion criteria will be entered into 3 groups in sequential order for a single dose. The dose-escalation study utilizes a "3+3" design, i.e., 3-6 subjects in each group will complete a single dose.
After the last subject in each dose group completes a dose-limiting toxicity (DLT) assessment window of 28 days after the single dose, enrollment in the next dose group can begin.
When 1 DLT occurs in 3 subjects in a dose group, 3 additional subjects are required in the same dose group (up to 6 subjects in that dose group have completed DLT assessment): if no ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • - Diagnosed relapsing/refractory systemic sclerosis that has failed treatment with at least two immunosuppressive and/or biologic agents.
- • Bone marrow and coagulation function, liver and kidney function, cardiopulmonary function are satisfied No serious mental disorders
- Exclusion Criteria:
- • - Malignancy other than AID disease within 5 years prior to screening Hepatitis B surface antigen (HBsAg) positive, AIDS, syphilis and other virus positive persons Severe heart disease
Trial Officials
zhu chen, doctor
Principal Investigator
The First Hospital Affiliated to the University of Science and Technology of China
About Persongen Biotherapeutics (Suzhou) Co., Ltd.
Persongen Biotherapeutics (Suzhou) Co., Ltd. is a pioneering biotechnology company specializing in the development of innovative gene therapies and biotherapeutics. With a strong focus on harnessing advanced genetic engineering techniques, Persongen aims to address unmet medical needs in the fields of oncology and rare genetic disorders. The company is committed to leveraging cutting-edge research to deliver transformative treatments that improve patient outcomes. By fostering collaborative partnerships and adhering to rigorous clinical standards, Persongen Biotherapeutics is dedicated to advancing the frontiers of personalized medicine and enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hefei, Anhui, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported