Clinical Trial: NCT04186520
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | Medical College of Wisconsin |
| Information Provided By: | Medical College of Wisconsin |
| Last Update Posted: | 2026-02-23 |
Study Overview
Brief Summary
This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.
Official Title
Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
Conditions
Non Hodgkin Lymphoma (NHL), Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma, Marginal Zone Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Central Nervous System Lymphoma
Intervention / Treatment
- Biological: 8/12-Day Production of Car-T Cells
- Biological: 8/12-Day Production of Cryopreserved Car-T Cells
- Biological: 12-Day Production of Car-T Cells
Other Study ID Numbers
- PRO00037171
Start Date (Actual)
2020-05-18
Primary Completion Date (Estimated)
2027-02-28
Study Completion Date (Estimated)
2029-02-28
Enrollment (Estimated)
100
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Medical College of Wisconsin |
| Information Provided By: | Medical College of Wisconsin |
| Last Update Posted: | 2026-02-23 |
Study Overview
Brief Summary
This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.
Official Title
Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
Conditions
Non Hodgkin Lymphoma (NHL), Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma, Marginal Zone Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Central Nervous System Lymphoma
Intervention / Treatment
- Biological: 8/12-Day Production of Car-T Cells
- Biological: 8/12-Day Production of Cryopreserved Car-T Cells
- Biological: 12-Day Production of Car-T Cells
Other Study ID Numbers
- PRO00037171
Start Date (Actual)
2020-05-18
Primary Completion Date (Estimated)
2027-02-28
Study Completion Date (Estimated)
2029-02-28
Enrollment (Estimated)
100
Study Type
Interventional
Phase
Phase 1, Phase 2