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

NCT04911478 | Active Not Recruiting FDA Drug

• 1 other identifier: ADI-20200102
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Keywords

B-Cell lymphoma; CAR-T; Cell Therapy; Allogeneic Cell Therapy; T cells gamma delta; Immunotherapy, Adoptive; Antigens, CD20

Outcome Measures

Primary Outcomes (1)

• Long-term safety of Adicet Bio allogeneic γδ CAR T cell products

  Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies

  15 years

Secondary Outcomes (8)

• Measure quantitative immunoglobulin and peripheral blood immunophenotyping

  15 years post last treatment

• Monitor for the presence of replication competent retrovirus (RCR)

  15 years post last treatment

• Duration of ADI-001 persistence

  15 years post last treatment

• Overall Response Rate by Lugano Criteria

  15 years post last treatment

• Duration of Response by Lugano Criteria

  15 years post last treatment

Study Arms (1)

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

Interventions

ADI-001 GENETIC

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

Subjects from Adicet Bio allogeneic γδ CAR T cell interventional studies.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male or Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Adicet Therapeutics: lead

Study Sites (5)

Blood and Marrow Transplant Program

Palo Alto, California, 94304, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

MD Anderson Caner Center

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Test for RCR following treatment with Adicet Bio allogeneic CAR T cell products. Also will continue to follow immunogenicity assessments of Adicet Bio allogeneic CAR T cell products by using patients blood specimens to assess humoral as well as cellular responses to CAR T cell products. Persistence of ADI-001 will be measured in blood.

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 3, 2021
• Study Start: February 14, 2022
• Primary Completion (Estimated): August 1, 2038
• Study Completion (Estimated): August 1, 2039
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)