Clinical trial NCT04911478: Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells
Official title: Long-term Follow-up Protocol for Subjects Treated With Adicet Allogeneic Gamma Delta (γδ) CAR T Cell Investigational Products
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lymphoma, Follicular
Lymphoma, Mantle-Cell
Marginal Zone Lymphoma
Primary Mediastinal B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Lymphoma, Non-Hodgkin
Keywords: B-Cell lymphoma
CAR-T
Cell Therapy
Allogeneic Cell Therapy
T cells gamma delta
Immunotherapy, Adoptive
Antigens, CD20
Lead sponsor: Adicet Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Long-term safety of Adicet Bio allogeneic γδ CAR T cell products
timeFrame: 15 years
Secondary outcomes:
measure: Measure quantitative immunoglobulin and peripheral blood immunophenotyping
timeFrame: 15 years post last treatment
measure: Monitor for the presence of replication competent retrovirus (RCR)
timeFrame: 15 years post last treatment
measure: Duration of ADI-001 persistence
timeFrame: 15 years post last treatment
measure: Overall Response Rate by Lugano Criteria
timeFrame: 15 years post last treatment
measure: Duration of Response by Lugano Criteria
timeFrame: 15 years post last treatment
measure: Progression Free Survival by Lugano Criteria
timeFrame: 15 years post last treatment
measure: Time To Progression by Lugano Criteria
timeFrame: 15 years post last treatment
measure: Overall Survival
timeFrame: 15 years post last treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Houston
country: United States
facility: MD Anderson Caner Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: