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| Name | Class |
|---|---|
| Anhui Provincial Hospital | OTHER_GOV |
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This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10^6 cells per kg body weight.
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| 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 |
|---|---|---|
| Incidence of Dose Limiting Toxicities | To assess adverse events as dose limiting toxicities as defined by the protocol. | From infusion to Day 28 |
| Complete Remission | Proportion of patients in whom with morphologic complete remission (CR) | At Day 28 after ThisCART19 infusion |
| TRM: Treatment Related Mortality | The mortality related with ThisCART19 infusion. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve CR or chronic lymphocytic leukemia(CRi); for chronic lymphocytic leukemia (CLL) and lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, Ph.D | Contact | +86-18662604088 | jli@ctigen.com | |
| Ling He | Contact | +86-18626100886 | lhe@ctigen.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingbing Wang | 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 |
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| Duration of Response |
Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course. |
| Up to 1 year |
| Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability | Adverse events assessed according to NCI-CTCAE v5.0 criteria | From inclusion up to 1 year |
| Overall Survival Rate of 2 Years | The rate of patients whom alive at year 2 | At year 2 |
| Fundamenta Therapeutice Co.,Ltd | Recruiting | Suzhou | Jiangsu | China |
|