Hematologic Malignancy, Solid Malignancy
Conditions
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.
Interventions
OTHERNon Interventional
Safety and Efficacy Assessment
Sponsors
CRISPR Therapeutics AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Canada, Germany, United States
Outcome results
None listed