A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies
- Conditions
- Solid MalignancyHematologic Malignancy
- Interventions
- Other: Non Interventional
- Registration Number
- NCT06208878
- Lead Sponsor
- CRISPR Therapeutics AG
- Brief Summary
This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies
- Detailed Description
All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 70
- Able to understand and comply with protocol-required study procedures and voluntarily sign and date a written informed consent document.
- Must have received CRISPR CAR T cellular therapy.
- There are no specific exclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non Interventional Non Interventional All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study.
- Primary Outcome Measures
Name Time Method The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment. 15 years The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized.
- Secondary Outcome Measures
Name Time Method The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment 15 years Overall survival will be calculated as the time between the initial dose of CRISPR CAR T cellular therapy in the parent study and death due to any cause. Duration of remission/response will be calculated as the time between the first objective response to first disease progression or death due to any cause.
Trial Locations
- Locations (21)
Stanford
🇺🇸Stanford, California, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Peter MacCallum Cancer Center
🇦🇺Melbourne, Victoria, Australia
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Utah-Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
City of Hope
🇺🇸Duarte, California, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
Emory
🇺🇸Atlanta, Georgia, United States
University of Kansas
🇺🇸Westwood, Kansas, United States
Washington University Saint Louis
🇺🇸Saint Louis, Missouri, United States
MSKCC
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Methodist Hospital-Sarah Cannon
🇺🇸San Antonio, Texas, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
University Hospital Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Sir Charles Gairdner
🇦🇺Nedlands, Australia
Princess Margaret
🇨🇦Toronto, Ontario, Canada
Montefiore Medical Center
🇺🇸Bronx, New York, United States