Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure quantitative immunoglobulin and peripheral blood immunophenotyping | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male or Female
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood and Marrow Transplant Program | Palo Alto | California | 94304 | United States | ||
| Norton Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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 | 15 years post last treatment |
| Overall Response Rate by Lugano Criteria | Overall Response Rate by Lugano Criteria | 15 years post last treatment |
| Duration of Response by Lugano Criteria | Duration of Response by Lugano Criteria | 15 years post last treatment |
| Progression Free Survival by Lugano Criteria | Progression Free Survival by Lugano Criteria | 15 years post last treatment |
| Time To Progression by Lugano Criteria | Time To Progression by Lugano Criteria | 15 years post last treatment |
| Overall Survival | Overall Survival from date of first treatment until date of death | 15 years post last treatment |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75204 | United States |
| MD Anderson Caner Center | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided