Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells

June 7, 2022 updated by: Adicet Bio, Inc

Long-term Follow-up Protocol for Subjects Treated With Adicet Allogeneic Gamma Delta (γδ) CAR T Cell Investigational Products

The purpose of this study is to assess long-term side effects from subjects who receive an Adicet Bio γδ CAR T cell product. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years from the first administration of Adicet Bio allogeneic γδ CAR T cell product, subjects will be assessed for long-term safety and survival through collection of data that include safety, efficacy, pharmacokinetics and immunogenicity.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who received an Adicet Bio allogeneic γδ CAR T cell product that has been genetically engineered to express the anti-CD20 CAR by transduction with a self-inactivating, replication incompetent gamma retroviral vector. The period of follow-up is 15 years after the administration of the γδ CAR T cell product.

The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to a genetically engineered CAR in Adicet Bio clinical studies. Upon early termination/discontinuation or completion of the parent interventional study, subjects will enroll into this study. Collection of these data will further define the risk-benefit and efficacy profile Adicet allogeneic γδ CAR T cell investigational products.

This is an observational study, and the elements of the study design are per published guidelines for gene therapy medicinal products that utilize integrating viral vectors such as gamma retrovirus and it is important to evaluate any delayed adverse events after infusion with such products.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • Texas
      • Dallas, Texas, United States, 75204
        • Baylor Scott & White Research Institute
      • Houston, Texas, United States, 77030
        • MD Anderson Caner Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04735471 or any protocol in which patients were administered Adicet allogeneic γδ CAR T cell. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post infusion and will continue to be monitored for safety, immunogenicity and efficacy.

Description

Inclusion Criteria:

  • All patients who received any Adicet allogeneic CAR T investigational product and have either completed the core treatment protocol or have discontinued early
  • All patients who are willing and able to adhere to the study visit schedule and other protocol requirements.
  • Capable of giving signed informed consent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and protocol

Exclusion Criteria:

  • There are no specific exclusion criteria for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects from Adicet Bio allogeneic γδ CAR T cell interventional studies.

This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in Adicet Bio allogeneic γδ CAR T cell study.

Patients will be followed for up to 15 years post treatment of Adicet Bio allogeneic γδ CAR T cell investigational products.
Genetic: ADI-001
No study drug is administered in this study. Patients who have received Adicet allogeneic γδ CAR T cell therapy will be evaluated in this trial for long-term safety and efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety of Adicet Bio allogeneic γδ CAR T cell products
Time Frame: 15 years
Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure quantitative immunoglobulin and peripheral blood immunophenotyping
Time Frame: 15 years post last treatment
15 years post last treatment
Monitor for the presence of replication competent retrovirus (RCR)
Time Frame: 15 years post last treatment
Test for RCR following treatment with Adicet Bio allogeneic γδ CAR T cell products by QCR analysis
15 years post last treatment
Duration of ADI-001 persistence
Time Frame: 15 years post last treatment
Defined as duration from dosing to undetectable levels of Adicet allogeneic γδ CAR T cell per microliter blood
15 years post last treatment
Overall Response Rate by Lugano Criteria
Time Frame: 15 years post last treatment
Overall Response Rate by Lugano Criteria
15 years post last treatment
Duration of Response by Lugano Criteria
Time Frame: 15 years post last treatment
Duration of Response by Lugano Criteria
15 years post last treatment
Progression Free Survival by Lugano Criteria
Time Frame: 15 years post last treatment
Progression Free Survival by Lugano Criteria
15 years post last treatment
Time To Progression by Lugano Criteria
Time Frame: 15 years post last treatment
Time To Progression by Lugano Criteria
15 years post last treatment
Overall Survival
Time Frame: 15 years post last treatment
Overall Survival from date of first treatment until date of death
15 years post last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adicet Bio, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Anticipated)

August 1, 2038

Study Completion (Anticipated)

August 1, 2039

Study Registration Dates

First Submitted

May 23, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADI-20200102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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