Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThisCART19 cells injections | Experimental | In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThisCART19 cells | Biological | 0.2-60 x 10^6 CAR T cells per kg body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse events | Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0 | 90 days post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Remission Rate (ORR) | Anti-tumor efficacy by 2014 Lugano criteria | up to 90 days |
| Progression free survival time | The interval between administration and disease progression or death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, Ph.D | Contact | 18662604088 | jli@ctigen.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhengyu Li, Ph.D | The Affiliated Hospital of Xuzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 years |
| Overall survival time | The interval between administration and death caused by any reason | 3 years |
| Event-free survival (EFS) | EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit. | 3 years |