Menu
Enrolling by invitation NCT06208878

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

— Observational Hematologic Malignancy Solid Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non Interventional.
Who it may be relevant to
Registry conditions: Hematologic Malignancy, Solid Malignancy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies

Overview

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

  • Other Non Interventional
    Safety and Efficacy Assessment

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment [Time frame: 15 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 17 centers
  • City of Hope — Duarte
  • Cedars Sinai — Los Angeles
  • Stanford — Stanford
  • Yale New Haven Hospital — New Haven
  • Emory — Atlanta
  • University of Chicago — Chicago
  • University of Kansas — Westwood
  • University of Minnesota — Minneapolis
  • … and 9 more centers
Australia · 3 centers
  • Royal Prince Alfred Hospital — Camperdown
  • Peter MacCallum Cancer Center — Melbourne
  • Sir Charles Gairdner — Nedlands
Canada · 1 center
  • Princess Margaret — Toronto
Germany · 1 center
  • University Hospital Hamburg-Eppendorf — Hamburg

Identifiers

NCT: NCT06208878 · CRSP-ONC-LTF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗