Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a phase I/II trial to assess safety, dose finding and feasibility of ex vivo generated MB-CART20.1 cells in patients with relapsed or refractory CD20 positive B-NHL.
MB-CART20.1 consists of autologous Anti-CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in Non-Hodgkin-Lymphoma (NHL)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I - Safety Dose Level | Experimental | In phase I three (3) + 3 patients will be treated with 1x10^5 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the preceding safety dose level |
|
| Phase I - Dose Level 1 | Experimental | In phase I six (6) + 3 patients will be treated with 1x10^6 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the dose level 1 |
|
| Phase I - Dose Level 2 | Experimental | In phase I six (6) + 3 patients will be treated with 3x10^6 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the dose level 2 |
|
| Phase II | Experimental | The number of additional patients who will be treated with MB-CART20.1 cells in Phase II is depending on the number of evaluable patients treated with the maximum tolerated dose (MTD) level and the results in Part I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB-CART20.1 | Biological | MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in NHL |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I - Determination of the maximum tolerated dose (MTD) | MTD is defined as the highest dose level at which < 33% of patients experience Dose Limiting Toxicity (DLT). Safety and toxicity assessment of MB-CART20.1 per adverse events (AE) reporting classified according to CTCAE version 5.0. | until day 28 after infusion of MB-CART20.1 |
| Phase II - Best overall response rate | Response (Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD)) is defined according to Cheson criteria. | 3 months after infusion of MB-CART20.1 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I - Related safety and toxicity of MB-CART20.1 | Per adverse events (AE) reporting classified according to CTCAE version 5.0. | months 3, 6, 9 and 12 after infusion of MB-CART20.1 |
| Phase I - Best overall response rate over 4 weeks and 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Borchmann, Prof. Dr. | Universitätsklinikum Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne - Clinic for Internal Medicine I | Cologne | 50937 | Germany | |||
| Universitätsklikum Leipzig, AöR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
| 4 weeks and 3 months after infusion of MB-CART20.1 |
| Phase I - Best overall response rate over 1 year | Response (CR, PR, SD and PD) is defined according to Cheson criteria. | 1 year after infusion of MB-CART20.1 |
| Phase I - Occurrence of B-cell aplasia | Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry. | 1 year after infusion of MB-CART20.1 |
| Phase I - Phenotype and Persistence of MB-CART20.1 | Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed. | 1 year after infusion of MB-CART20.1 |
| Phase II - Best overall response rate over 1 year | Response (CR, PR, SD and PD) is defined according to Cheson criteria. | 1 year after infusion of MB-CART20.1 |
| Phase II - Overall response rate over 4 weeks and 3 months | Response (CR, PR, SD and PD) is defined according to Cheson criteria. | 4 weeks and 3 months after infusion of MB-CART20.1 |
| Phase II - Overall response rate over 1 year | Response (CR, PR, SD and PD) is defined according to Cheson criteria. | 1 year after infusion of MB-CART20.1 |
| Phase II - Number of patients with CR, PR, SD and PD | Response (CR, PR, SD and PD) is defined according to Cheson criteria. | 1 year after infusion of MB-CART20.1 |
| Phase II -Percentage of patients with CR, PR, SD and PD | Response (CR, PR, SD and PD) is defined according to Cheson criteria. | 1 year after infusion of MB-CART20.1 |
| Phase II - Safety and toxicity assessment of MB-CART20.1 | Per adverse events (AE) reporting classified according to CTCAE version 5.0. | 1 year after infusion of MB-CART20.1 |
| Phase II - Occurrence of B-cell aplasia | Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry. | 1 year after infusion of MB-CART20.1 |
| Phase II - Phenotype and Persistence of MB-CART20.1 | Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed. | 1 year after infusion of MB-CART20.1 |
| Leipzig |
| Germany |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |