Lymphoma, FollicularNCT04911478
Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells
An observational study of Lymphoma, Follicular and Lymphoma, Mantle-Cell, run by Adicet Therapeutics at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular, Lymphoma, Mantle-Cell, Marginal Zone Lymphoma
- What is being tested?
- ADI-001
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Feb 2022to Aug 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- There are no specific exclusion criteria for this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Baylor Scott & White Research Institute
Dallas, Texas, 75204
MD Anderson Caner Center
Houston, Texas, 77030
Norton Cancer Institute
Louisville, Kentucky, 40207
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Blood and Marrow Transplant Program
Palo Alto, California, 94304
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphoma, Follicular, Lymphoma, Mantle-Cell, Marginal Zone Lymphoma, Primary Mediastinal B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Lymphoma, Non-Hodgkin
- Being tested
- ADI-001
- Keywords
- B-Cell lymphoma, CAR-T, Cell Therapy, Allogeneic Cell Therapy, T cells gamma delta, Immunotherapy, Adoptive, Antigens, CD20
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-001Genetic
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: ADI-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of Adicet Bio allogeneic γδ CAR T cell products
Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies
Measured: 15 years
Secondary outcomes (8)
Measure quantitative immunoglobulin and peripheral blood immunophenotyping
Measured: 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
Measured: 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
Measured: 15 years post last treatment
Overall Response Rate by Lugano Criteria
Overall Response Rate by Lugano Criteria
Measured: 15 years post last treatment
Duration of Response by Lugano Criteria
Duration of Response by Lugano Criteria
Measured: 15 years post last treatment
Progression Free Survival by Lugano Criteria
Progression Free Survival by Lugano Criteria
Measured: 15 years post last treatment
Time To Progression by Lugano Criteria
Time To Progression by Lugano Criteria
Measured: 15 years post last treatment
Overall Survival
Overall Survival from date of first treatment until date of death
Measured: 15 years post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start14 Feb 2022
- Primary completionAug 2038 (estimated)
- Study completionAug 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adicet Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911478
- Sponsor's protocol ID
- ADI-20200102
- Status last verified
- Apr 2026
- First submitted
- 23 May 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Protocol for Subjects Treated With Adicet Allogeneic Gamma Delta (γδ) CAR T Cell Investigational Products
- ClinicalTrials.gov ID
- NCT04911478
- Acronym / sponsor ID
- ADI-20200102
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adicet TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- Aug 2038 (estimated)
- Study completion
- Aug 2039 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects from Adicet Bio allogeneic γδ CAR T cell interventional studies. | – | Genetic: ADI-001This 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-001No 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 | Genetic | Subjects from Adicet Bio allogeneic γδ CAR T cell interventional studies. |
Primary outcome
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
8 secondary outcomes
Measure quantitative immunoglobulin and peripheral blood immunophenotyping
Time frame: 15 years post last treatment
Monitor for the presence of replication competent retrovirus (RCR)
Time frame: 15 years post last treatment
Duration of ADI-001 persistence
Time frame: 15 years post last treatment
Overall Response Rate by Lugano Criteria
Time frame: 15 years post last treatment
Duration of Response by Lugano Criteria
Time frame: 15 years post last treatment
Progression Free Survival by Lugano Criteria
Time frame: 15 years post last treatment
Time To Progression by Lugano Criteria
Time frame: 15 years post last treatment
Overall Survival
Time frame: 15 years post last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Follicular and Lymphoma, Mantle-Cell, run by Adicet Therapeutics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety of Adicet Bio allogeneic γδ CAR T cell products (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.