An observational study in Lymphoma, Follicular, Lymphoma, Mantle-Cell and Marginal Zone Lymphoma, sponsored by Adicet Therapeutics. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Adicet Therapeutics · Observational
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.
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.
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 195 observational studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Adicet Therapeutics is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Long-term safety of Adicet Bio allogeneic γδ CAR T cell products
Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies
Time frame: 15 years
Measure quantitative immunoglobulin and peripheral blood immunophenotyping
Time frame: 15 years post last treatment
Monitor for the presence of replication competent retrovirus (RCR)
Test for RCR following treatment with Adicet Bio allogeneic γδ CAR T cell products by QCR analysis
Time frame: 15 years post last treatment
Duration of ADI-001 persistence
Defined as duration from dosing to undetectable levels of Adicet allogeneic γδ CAR T cell per microliter blood
Time frame: 15 years post last treatment
Overall Response Rate by Lugano Criteria
Overall Response Rate by Lugano Criteria
Time frame: 15 years post last treatment
Duration of Response by Lugano Criteria
Duration of Response by Lugano Criteria
Time frame: 15 years post last treatment
Progression Free Survival by Lugano Criteria
Progression Free Survival by Lugano Criteria
Time frame: 15 years post last treatment
Time To Progression by Lugano Criteria
Time To Progression by Lugano Criteria
Time frame: 15 years post last treatment
Overall Survival
Overall Survival from date of first treatment until date of death
Time frame: 15 years post last treatment
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Aug 2038, 198 months after the start.
Of 81 observational studies under Lymphoma, Follicular, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 120. This study's planned 198 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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