A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies

Brief Summary
This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies
Brief Title
A Long-term Follow-up Study of Subjects Who Received 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.
Completion Date
Completion Date Type
Estimated
Conditions
Hematologic Malignancy
Solid Malignancy
Eligibility Criteria
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.
Inclusion Criteria
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.

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06208878
Org Class
Industry
Org Full Name
CRISPR Therapeutics
Org Study Id
CRSP-ONC-LTF
Overall Status
Enrolling by invitation
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies
Primary Outcomes
Outcome Description
The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized.
Outcome Measure
The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.
Outcome Time Frame
15 years
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
15 years
Outcome Measure
The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Study Population
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Roberto Alejandro Sica
Investigator Email
asica@montefiore.org