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achieved the proof of concept
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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).
This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C (GCC)-positive advanced gastrointestinal tumors. Subjects who meet the eligibility criteria will receive LCAR-G08 infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chimeric Antigen Receptor T cell LCAR-G08 Cells | Experimental | Each subject will receive LCAR-G08 Cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCAR-G08 cells | Biological | Prior to infusion of the LCAR-G08, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) rate | Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Incidence, severity, and type of treatment-emergent adverse events (TEAEs) | An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Recommended Phase 2 Dose (RP2D) regimen finding | RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Maximum concentration (Cmax) | The maximum observed concentration of CAR positive T cells or transgene CAR copy number after LCAR-G08 infusion. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Time to Cmax (Tmax) | The time it takes to reach the maximum concentration or time to Cmax after LCAR-G08 infusion. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Time to the last observed concentration | The time it takes to reach the last observed concentration after LCAR-G08 infusion. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) after administration | Objective Response Rate (ORR) is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LCAR-G08 cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 only. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital & Institute | Beijing | Beijing Municipality | 100142 | China | ||
| Beijing GoBroad Hospital |
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Model Description
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Masking Description
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| Area Under the Curve (AUC) last | The total exposure of the drug experienced by the subject in a clinical study from LCAR-G08 infusion to time to the last observed concentration. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Disease Control Rate (DCR) after administration | Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Duration of Remission (DoR) after administration | Duration of Remission (DoR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders (who achieve PR or better response).se). | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Time to Response (TTR) after administration | Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-G08 to the date of the first response evaluation of the subject who has met all criteria for PR or better. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Progression-free Survival (PFS) after administration | Progression-free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-G08 to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Overall Survival (OS) after administration | Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-G08 to death of the subject. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Incidence of anti-LCAR-G08 antibody and positive sample titer | Venous blood samples will be collected to measure LCAR-G08 positive cell concentrations and the transgenic level of LCAR-G08, at the time points when anti-LCAR-G08 antibody serum samples are evaluated. | Minimum 2 years after LCAR-G08 infusion (Day 1) |
| Beijing |
| Beijing Municipality |
| 102200 |
| China |