Long-term Follow-up Study of Patients Receiving CAR-20/19-T Cells
Study Details
Study Description
Brief Summary
This protocol is designed as a long-term follow-up study of participants who will receive genetically modified autologous CAR-T cells as part of clinical trial at the Medical College of Wisconsin/ Froedtert Hospital-- Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The objective is to follow participants receiving cluster of differentiation (CD) 20 / cluster of differentiation (CD) 19 lentiviral modified CAR-T cells (CAR-20/19-T cells) from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants who received CAR-20/19-T cells. Participants who received CAR-20/19-T cells in study NCT03019055. |
Other: Long-Term Follow-Up of Participants who Received CAR-20/19-T cells
No study drug is administered in this study. Participants who received CAR-20/19-T cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.
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Outcome Measures
Primary Outcome Measures
- Change from baseline in the incidence of new malignancies. [Every 6 months from years 2-5 post-infusion then yearly from year 6-15.]
The number of subjects with new malignancies.
- Change from baseline in the exacerbation of a prior rheumatologic or other autoimmune disorder. [Every 6 months from years 2-5 post-infusion then yearly from year 6-15.]
The number of subjects with exacerbation of a prior rheumatologic or other autoimmune disorder.
- Change from baseline in the incidence of a new hematologic disorder. [Every 6 months from years 2-5 post-infusion then yearly from year 6-15.]
The number of subjects with new hematologic disorders.
Secondary Outcome Measures
- Change from baseline in the number of participants who are disease free two years post-infusion. [Two years post-infusion.]
The number of subjects who relapse or progress among subjects who are disease free two years post-transplant.
- Change from baseline in overall survival rate. [Every 6 months from years 2-5 post-infusion then yearly from year 6-15.]
The number of subjects who are alive.
- Change from baseline in the absolute B- and T-lymphocyte counts. [Every 6 months from years 2-5 post-infusion then yearly from year 6-15.]
The number of cells measured by 10^3 cells/µL.
- Change from baseline in the proportion of participants with persistent CAR-20/19-T cells. [Every 6 months from years 2-5 post-infusion then yearly from year 6-15.]
The number of participants with persistent cells measured by by integrated vector DNA by quantitative polymerase chain reaction.
- Change from baseline in the recovery of immunoglobulin production as measured by quantitative immunoglobulin levels. [Every 6 months from years 2-5 post-infusion then yearly from year 6-15.]
This measure will be the serum concentration of Immunoglobin A (IgA), immunoglobin G (IgG) and immunoglobin M (IgM).
Eligibility Criteria
Criteria
Inclusion Criteria:
- All participants who enrolled in the Phase 1 CAR-20/19-T cell study at Froedtert & the Medical College of Wisconsin.
Exclusion Criteria:
- There are no exclusion criteria for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Froedtert Hospital & Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Medical College of Wisconsin
Investigators
- Principal Investigator: Nirav Shah, Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO30317