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Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AUTO CAR T cell therapy | Experimental | Patients who received previous treatment with AUTO CAR T Cell Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUTO CAR T cell therapy | Biological | No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy | Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy. Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion. | For up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival following first AUTO CAR T cell therapy infusion. | Overall Survival following first AUTO CAR T cell therapy infusion. | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 |
| Duration of supportive care |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Washington University in St. Louis |
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B-cell aplasia for patients treated with an AUTO CAR T cell therapy targeting a B-cell malignancy. |
| Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 |
| Duration of response | Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression. | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 |
| Progression-free survival | Progression free survival following first AUTO CAR T cell therapy infusion. | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 |
| Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion | Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion | For up to 15 years |
| Proportion of patients with detectable vector copy number (VCN) in peripheral blood | Blood sample collection for VCN measurement to detect persistence of CAR transgene(s) | Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15 |
| Testing for Insertional mutagenesis in case of a new malignancy | Insertional site analysis of samples to determine insertional mutagenesis as a potential cause / contributor in case of a new malignancy. | For up to 15 years |
| St Louis |
| Missouri |
| 63110 |
| United States |
| St David's South Austin Medical Center | Austin | Texas | 78704 | United States |
| Queen Elizabeth University Hospital | Glasgow | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | United Kingdom |
| Manchester Royal Infirmary Hospital | Manchester | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | United Kingdom |
| Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
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