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

N/AEnrolling By InvitationNCT06208878

CRISPR Therapeutics AG70 enrolled

Overview

This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hematologic Malignancy Solid Malignancy

Interventions

Non InterventionalOTHER

Safety and Efficacy Assessment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

City of Hope

Duarte, California, United States

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.

The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized.

Time frame: 15 years

Secondary Outcomes

The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment

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.

Time frame: 15 years

Data from ClinicalTrials.gov

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