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| Name | Class |
|---|---|
| Fundamenta Therapeutics, Ltd. | INDUSTRY |
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This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.
This is a phase 1, single-center, nonrandomized, open-label, dose-escalation and dose expansion study to evaluate the safety and efficacy of ThisCART19A in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThisCART19A cells infusion | Experimental | In this study, allogeneic anti-CD19 CAR T cell (ThisCART19A) infusion is used to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThisCART19A | Drug | ThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy . |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity(DLT) observation in patient with B Cell Malignancy in each dose level during dose escalation stage | DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level. | 28 days |
| Objective Response Rate within 3 months during dose expansion stage | For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve Complete Response (CR) or Complete Response With Incomplete Hematologic Recovery (CRi); for lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). | 3 months |
| Minimum Residual Disease (MRD) Negative Remission Rate within 3 months during dose expansion stage | MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. Percentage of participants with MRD negative remission was reported. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response(DOR) during dose escalation stage and expansion stage | DOR was defined as the time from first CR/CRi or PR to relapse or any death in the absence of documented relapse. | 24 months |
| Relapse-free Survival (RFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keshu zhou, Dr. | Contact | +86-13674902391 | drzhouks77@163.com | |
| Jun Li, Ph.D | Contact | +86-18662604088 | jli@ctigen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan cancer hospital | Zhengzhou | Henan | China |
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| Fludarabine Pill | Drug | Fludarabine is used for lymphodepletion. |
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| Cyclophosphamide | Drug | Cyclophosphamide is used for lymphodepletion. |
|
| VP-16 Protocol | Drug | VP-16 is used for lymphodepletion. |
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RFS is defined as the time from the date of ThisCART19A infusion to the date of disease relapse or death from any cause.
| 24 months |
| Event-free Survival (EFS) | EFS is defined as the time from the date of ThisCART19A infusion to the date of disease relapse, progression, genetic relapse or death from any cause. | 24 months |
| Overall Survival (OS) | OS is defined as the time from the date of ThisCART19A infusion to the date of death from any cause. | 24 months |
| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| C038959 | CBV protocol |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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