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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04911478
• Other study ID #: ADI-20200102
• Status: Enrolling by invitation
• Start date: February 14, 2022
• Est. completion date: August 2039

Study information

• Verified date: June 2022
• Source: Adicet Bio, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: August 2039
• Est. primary completion date: August 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Marginal Zone Lymphoma
• Primary Mediastinal B-cell Lymphoma

Intervention

Genetic:
• ADI-001
No study drug is administered in this study. Patients who have received Adicet allogeneic ?d CAR T cell therapy will be evaluated in this trial for long-term safety and efficacy

Locations

Country	Name	City	State
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	MD Anderson Caner Center	Houston	Texas
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Adicet Bio, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety of Adicet Bio allogeneic ?d CAR T cell products	Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies	15 years
Secondary	Measure quantitative immunoglobulin and peripheral blood immunophenotyping		15 years post last treatment
Secondary	Monitor for the presence of replication competent retrovirus (RCR)	Test for RCR following treatment with Adicet Bio allogeneic ?d CAR T cell products by QCR analysis	15 years post last treatment
Secondary	Duration of ADI-001 persistence	Defined as duration from dosing to undetectable levels of Adicet allogeneic ?d CAR T cell per microliter blood	15 years post last treatment
Secondary	Overall Response Rate by Lugano Criteria	Overall Response Rate by Lugano Criteria	15 years post last treatment
Secondary	Duration of Response by Lugano Criteria	Duration of Response by Lugano Criteria	15 years post last treatment
Secondary	Progression Free Survival by Lugano Criteria	Progression Free Survival by Lugano Criteria	15 years post last treatment
Secondary	Time To Progression by Lugano Criteria	Time To Progression by Lugano Criteria	15 years post last treatment
Secondary	Overall Survival	Overall Survival from date of first treatment until date of death	15 years post last treatment