Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients may be enrolled following their AUTO CAR T cell therapy treatment and will be followed for up to 15 years (or death, whichever happens first) after the first AUTO CAR T cell therapy infusion. Patients will be monitored for safety following the first AUTO CAR T cell therapy infusion.

Official Title
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Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors

Conditions
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Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma, DLBCL, ALL, Adult and Pediatric, T Cell Lymphoma

Intervention / Treatment
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* Biological: AUTO CAR T cell therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have received an AUTO CAR T cell therapy on a clinical treatment study. Patients must have provided informed consent for long-term follow-up study prior to participation. Patients must be able to comply with the study requirements. Exclusion Criteria: There are no specific exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AUTO CAR T cell therapy<br>Patients who received previous treatment with AUTO CAR T Cell Therapy | Biological: AUTO CAR T cell therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events, new malignancies & adverse events of special interest related to AUTO CAR T cell therapy | Monitoring of all serious adverse events/ adverse events of special interest, 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| B-Cell / T-cell aplasia | Duration of supportive care | 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 |