A Long-term Follow-up Study of Participants Who Received an Allogeneic CAR T-Cell Product

Sponsor

Precision BioSciences, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05822427

Collaborator

(none)

Enrollment

Location

231.2

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to collect information on the long-term safety of study participants who received Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in a

Precision BioSciences, Inc. (PBI) Clinical Study. The main questions it aims to answer are:

-What were the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?

Participants will visit a study center 3 times during the first year, and once per year after that for a physical exam and other assessments to check for CEI.

Condition or Disease	Intervention/Treatment	Phase
Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study

Detailed Description

This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in a PBI clinical study involving PBCAR product dosing. This study protocol does not include administration of a PBCAR product; however, subjects may receive investigational products other than a PBCAR product through participation in other clinical studies during the period of this observational study.

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in a Precision BioSciences, Inc., Clinical Study

Actual Study Start Date :

Aug 25, 2020

Anticipated Primary Completion Date :

Dec 1, 2039

Anticipated Study Completion Date :

Dec 1, 2039

Outcome Measures

Primary Outcome Measures

Frequency of Clinically Significant Clinical Events of Interest (CEI) [Up to 15 years]
Severity of Clinically Significant CEI [Up to 15 years]
Duration of Clinically Significant CEI [Up to 15 years]
Outcome of Clinically Significant CEI [Up to 15 years]

Secondary Outcome Measures

Duration of Disease Response [Up to 15 years]
Overall Survival Rate [Up to 15 years]
Occurrence of Secondary Malignancy [Up to 15 years]
PBCAR Persistence [Up to 15 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Receipt of at least 1 dose of PBCAR product in a PBI clinical study.
A signed informed consent form (ICF).
Willingness and ability to adhere to the study schedule and all other protocol requirements.

Exclusion Criteria:

No unique exclusion criteria apply to this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Science 37, Inc.	Culver City	California	United States	90230

Sponsors and Collaborators

Precision BioSciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Precision BioSciences, Inc.

ClinicalTrials.gov Identifier:

NCT05822427

Other Study ID Numbers:

PBCAR-LTF

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 20, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Precision BioSciences, Inc.

PBCAR

Allogeneic chimeric antigen receptor (CAR) T cell products

Study Results

No Results Posted as of Apr 20, 2023