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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001393-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Uppsala University Hospital | OTHER |
| Karolinska University Hospital | OTHER |
| AFA Insurance | INDUSTRY |
| Swedish Cancer Society |
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Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR T cells | Experimental | Autologous 3rd generation CD19-targeting CAR T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous 3rd generation CD19-targeting CAR T cells | Biological | Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CAR T cell persistence | Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood. | At week 1 and 5, there after every 3 months post treatment up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor load | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. | Every 3 months post treatment up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| B cell number and immunoglobulins | Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics | Weekly for 5 weeks, then every 3 months post treatment up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelica Loskog, PhD | Uppsala University | Study Director |
| Gunilla Enblad, MD, PhD | Uppsala University Hospital | Principal Investigator |
| Hans Hagberg, MD, PhD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital, Dept of Oncology | Uppsala | 75185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515338 | Derived | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. | |
| 30097433 |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
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| Enblad G, Karlsson H, Gammelgard G, Wenthe J, Lovgren T, Amini RM, Wikstrom KI, Essand M, Savoldo B, Hallbook H, Hoglund M, Dotti G, Brenner MK, Hagberg H, Loskog A. A Phase I/IIa Trial Using CD19-Targeted Third-Generation CAR T Cells for Lymphoma and Leukemia. Clin Cancer Res. 2018 Dec 15;24(24):6185-6194. doi: 10.1158/1078-0432.CCR-18-0426. Epub 2018 Aug 10. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |