Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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
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Outcome Measures
Primary Outcome Measures
- Long-term safety of Adicet Bio allogeneic γδ CAR T cell products [15 years]
Occurrence of new Adverse Events of Special interests, Serious AEs and malignancies
Secondary Outcome Measures
- 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]
Test for RCR following treatment with Adicet Bio allogeneic γδ CAR T cell products by QCR analysis
- Duration of ADI-001 persistence [15 years post last treatment]
Defined as duration from dosing to undetectable levels of Adicet allogeneic γδ CAR T cell per microliter blood
- Overall Response Rate by Lugano Criteria [15 years post last treatment]
Overall Response Rate by Lugano Criteria
- Duration of Response by Lugano Criteria [15 years post last treatment]
Duration of Response by Lugano Criteria
- Progression Free Survival by Lugano Criteria [15 years post last treatment]
Progression Free Survival by Lugano Criteria
- Time To Progression by Lugano Criteria [15 years post last treatment]
Time To Progression by Lugano Criteria
- Overall Survival [15 years post last treatment]
Overall Survival from date of first treatment until date of death
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients who received any Adicet allogeneic CAR T investigational product and have either completed the core treatment protocol or have discontinued early
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All patients who are willing and able to adhere to the study visit schedule and other protocol requirements.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University Medical Center | Stanford | California | United States | 94305 |
| 2 | Norton Cancer Institute | Louisville | Kentucky | United States | 40207 |
| 3 | Baylor Scott & White Research Institute | Dallas | Texas | United States | 75204 |
| 4 | MD Anderson Caner Center | Houston | Texas | United States | 77030 |
| 5 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Adicet Bio, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADI-20200102