Lymphoma
Conditions
Keywords
ASCT, CD19 CAR-T
Brief summary
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Detailed description
Current studies have shown that under standard treatment, patients with large masses and high-grade DLBCL have a poor prognosis. Data from major centers around the world on CAR-T cell treatment of relapsed and refractory B-cell NHL show that CAR-T treatment of relapsed and refractory B-cell NHL has a low complete remission rate but a low recurrence rate after remission.Therefore, new treatment options are urgently needed to achieve long-term relief. CD19 CAR-T therapy as a consolidation therapy after high-dose melphalan and autologous hematopoietic stem cell transplantation has been used in a refractory MM patient at the University of Pennsylvania, and good research progress has been made. Craig S et al. studied the safety and effectiveness of CD19 CAR-T cell therapy after high-dose chemotherapy and autologous stem cell transplantation HDT-ASCT. The object of the study was relapsed and refractory non-Hodgkin's lymphoma, with 2-year progression-free survival ( PFS) is 30%. Therefore, autologous hematopoietic stem cell transplantation combined with CAR-T cell therapy is expected to improve the complete remission rate and long-term survival rate. In summary, the center intends to apply for a clinical trial of autologous hematopoietic stem cell transplantation combined with CAR-T cells for the treatment of refractory and relapsed non-Hodgkin's lymphoma.
Interventions
BIOLOGICALAutologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
The patient receives ECHOP chemotherapy or other chemotherapy regimens； G-CSF in the low cell stage mobilizes hematopoietic stem cells and freezes them for later use after collection； Autologous hematopoietic stem cells and prepared CD19 CAR-T cells are reinfused into the patient
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmed include: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphoma Subject. 3.R/R B-NHL (conform one of the following conditions) 1. The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy 2. Primary resistance 3. The subject relapsed after receiving autologous hematopoietic stem cell transplantation
Exclusion criteria
* Subjects with any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | Up to 30 months | the number of response patients/the number of total patients |
| Incidence of treatment-emergent adverse events (TEAEs) | 24 months after cell infusion | Incidence of treatment-emergent adverse events \[Safety and Tolerability\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(ORR) | Month 1,3,6,12,18and 24 | Assessment of ORR (ORR = CR + CRi ) at Month 1,3,6,12,18and 24 |
| Progression-free survival (PFS) | Month 6,12,18and 24 | Assessment of PFS at Month 6,12,18and 24 |
| Overall survival (OS) | Month 6,12,18and 24 | Assessment of OS at Month 6,12,18and 24 |
| Duration of response(DOR) | Month 6,12,18and 24 | Assessment of OS at Month 6,12,18and 24 |
Countries
China
Contacts
Primary ContactHe Huang, PhD
Backup ContactYongxian Hu, PhD
Outcome results
None listed