A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- CRISPR Therapeutics AG
- Enrollment
- 70
- Locations
- 46
- Primary Endpoint
- The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •There are no specific exclusion criteria.
Arms & Interventions
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.
Intervention: Non Interventional (Other)
Outcomes
Primary Outcomes
The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.
Time Frame: 15 years
The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized.
Secondary Outcomes
- The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment(15 years)