Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated due to changes in national policy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd | INDUSTRY |
| Suzhou Hongci Hematology Hospital, Suzhou, China | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.
Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASCT+CAR-T | Experimental | Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apheresis | Other | Participants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy. | Up to 24 months |
| Progression-free Survival(PFS) | PFS is defined as the time from ASCT to progression, death or the last follow-up point | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response(DOR) | To measure the duration of response to ASCT Plus CAR-T Cell Therapy over a follow-up period of 24 months | Up to 24 months |
| Complete Response Rate | Number of participants who will have achieved complete response after ASCT plus CAR-T cell Therapy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deipei Wu, M.D. | The First Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Autologous Stem Cell Transplantation | Other | Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10^6 CD34+ stem cells/kilogram. |
|
| CAR-T Cell Therapy | Drug | CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10^6 CAR-T/kg,ivgtt). |
|
|
| Up to 24 months |
| Overall Survival(OS) | OS will be assessed from ASCT plus CAR-T cell therapy to death or last follow-up. | Up to 24 months |
| Adverse events profile | Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated. | Up to 24 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007167 |
| Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |