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| Name | Class |
|---|---|
| CARsgen Therapeutics Co., Ltd. | INDUSTRY |
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This study is a single-arm, open-label, exploratory dose-escalation and dosefinding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with PCL.
This study is a single-arm, open-label, exploratory dose-escalation and dosefinding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with PCL. During the trial, dose increases or decreases or dose expansion may be performed using i3+3 principle based on the safety and ,tolerability and PK data of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T cells Infusion chimeric antigen receptor T cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T cells Infusion chimeric antigen receptor T cells | Drug | CAR-T cells Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) after CT0596 infusion | An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria | 12 months after CT0596 infusion |
| MTD and/or dose range | Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion | 12 months after CT0596 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) as assessed by the investigator | Overall response rate (ORR) defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria | 12 months after CT0596 infusion |
| Complete response/stringent complete response (CR/sCR) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D007952 | Leukemia, Plasma Cell |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009101 | Multiple Myeloma |
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Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on IMWG defined response criteria. |
| 12 months after CT0596 infusion |
| Rate of very good partial response (VGPR) and above | Rate of complete very good partial response response/stringent complete response (VGPR/CR/sCR) defined as proportion of patients achieving VGPR or better based on IMWG defined response criteria | 12 months after CT0596 infusion |
| Duration of response (DOR) | DOR is defined as the time from first achieving PR or better to confirmed disease progression or death from any cause | 12 months after CT0596 infusion |
| Minimal residual disease (MRD) negative rate | Minimal residual disease (MRD) negative rate is defined as the proportion of patients with VGPR or better who achieved 10-5 sensitivity of nucleated cell | 12 months after CT0596 infusion |
| Time to response (TTR) | TTR defined as the time from the date of infusion to the date of initial assessment of PR or better according to IMWG2016 criteria | 12 months after CT0596 infusion |
| Progression-free survival (PFS) | PFS defined as the time from the date of infusion of the subject to the first assessment of confirmed disease progression or death from any cause according to IMWG2016 criteria, whichever occurs first. | 12 months after CT0596 infusion |
| Peak value of CART cells | Time to peak expansion and peak expansion in plasma after infusion of CT0596 cells | 12 months after CT0596 infusion |
| Overall survival (OS) | OS defined as the time from the date of infusion of the subject to death from any cause | 12 months after CT0596 infusion |
| Cytokines in the peripheral blood after CT0596 infusion | Serum concentrations of interleukin (IL)-6 after CT0596 infusion | 12 months after CT0596 infusion |
| Area under the plasma concentration versus time curve (AUC) of CART cells | Area under the plasma concentration versus time curve (AUC) in plasma after infusion of CT0596 cells | 12 months after CT0596 infusion |
| In vivo persistence of CART cells | CART cells duration in plasma after infusion of CT0596 cells | 12 months after CT0596 infusion] |
| D054219 |
| Neoplasms, Plasma Cell |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |