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 First Affiliated Hospital of University of Science and Technology of China | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10^6 cells per kg body weight.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThisCART7 cells injections | Experimental | In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThisCART7 cells | Biological | 0.5-6 x 10^6 CAR T cells per kg body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-related grade≥3Adverse Events or SAE | Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). | within 4 weeks after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Description: For T-ALL, Objective response rate(ORR) is the percentage of patients who achieve CR or CRi, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology Acute Lymphoblastic Leukemia (2020.V1) ; For lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). Response will be assessed using the 2014 Lugano criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival time | The interval between administration and disease progression or death. | 3 years |
| Overall survival time | The interval between administration and death caused by any reason. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Jun, Ph.D | Contact | +86-18662604088 | jli@ctigen.com | |
| He Ling | Contact | +86-18626100886 | lhe@ctigen.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Xingbing | The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Recruiting | Hefei | Anhui | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 to 6 weeks after infusion |
| 3 years |
| Event-free survival | EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit. | 3 years |
| Fundamenta Therapeutice Co.,Ltd | Recruiting | Suzhou | Jiangsu | China |
|
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |