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
πΊπΈStanford, California, United States
UT Southwestern
πΊπΈDallas, Texas, United States
Peter MacCallum Cancer Center
π¦πΊMelbourne, Victoria, Australia
Yale New Haven Hospital
πΊπΈNew Haven, Connecticut, United States
University of Minnesota
πΊπΈMinneapolis, Minnesota, United States
Oregon Health and Science University
πΊπΈPortland, Oregon, United States
University of Utah-Huntsman Cancer Institute
πΊπΈSalt Lake City, Utah, United States
City of Hope
πΊπΈDuarte, California, United States
Cedars Sinai
πΊπΈLos Angeles, California, United States
Emory
πΊπΈAtlanta, Georgia, United States
University of Kansas
πΊπΈWestwood, Kansas, United States
Washington University Saint Louis
πΊπΈSaint Louis, Missouri, United States
MSKCC
πΊπΈNew York, New York, United States
University of Pennsylvania
πΊπΈPhiladelphia, Pennsylvania, United States
MD Anderson Cancer Center
πΊπΈHouston, Texas, United States
Methodist Hospital-Sarah Cannon
πΊπΈSan Antonio, Texas, United States
Royal Prince Alfred Hospital
π¦πΊCamperdown, New South Wales, Australia
University Hospital Hamburg-Eppendorf
π©πͺHamburg, Germany
Sir Charles Gairdner
π¦πΊNedlands, Australia
Princess Margaret
π¨π¦Toronto, Ontario, Canada
Montefiore Medical Center
πΊπΈBronx, New York, United States