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| Name | Class |
|---|---|
| SystImmune Inc. | INDUSTRY |
| Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. | INDUSTRY |
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To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT
phase Ib: To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2Dof GNC-038, or the MAD and DLT of GNC-038 if MTD is not reached, by intravenous infusion (IV, QW) once a week (2 weeks as a cycle) phase II To explore the efficacy of GNC-038 in patients with relapsed or refractory non-Hodgkin's lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment | Experimental | Participants receive GNC-038 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNC-038 | Drug | Administration by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0). | Up to 14 days after the first dose |
| Maximum tolerated dose (MTD) or Maximum dose (MAD) | In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD. | Up to 14 days after the first dose |
| Adverse Events during Treatment (TEAE) | TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-038. The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-038. | Up to approximately 24 months |
| Recommended dose for Phase II clinical studies (RP2D) | The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-038. | Up to 14 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate (DCR) | Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response. |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody (Nab) in phase Ⅰb | Incidence and titer of Nab of GNC-038 will be evaluated. | Up to approximately 24 months |
| Overall survival (OS) in phaseⅠb and phase Ⅱ | The time between the start of study medication and death. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sa Xiao, PHD | Contact | +86-15013238943 | xiaosa@baili-pharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhu | Peking University Cancer Hospital & Institute | Principal Investigator |
| Yuqin Song | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Up to approximately 24 months |
| progression-free survival (PFS) | The PFS is defined as the time from the participant's first dose of GNC-038 to the first date of either disease progression or death, whichever occurs first. | Up to approximately 24 months |
| Adverse Events of Special Interest (AESI) | AESI is an event of scientific and medical interest specific to the sponsor's product or research project. | Up to approximately 24 months |
| Cmax | Maximum serum concentration (Cmax) of GNC-038 will be investigated. | Up to approximately 24 months |
| Tmax | Time to maximum serum concentration (Tmax) of GNC-038 will be investigated. | Up to approximately 24 months |
| AUC0-INF | Blood concentration - Area under time line. | Up to approximately 24 months |
| AUC0-T | Blood concentration - Area under time line. | Up to approximately 24 months |
| T1/2 | Blood concentration - Area under time line. | Up to approximately 24 months |
| anti-drug antibody (ADA) in Ⅰa | Frequency and titer of anti-GNC-038 antibody (ADA). | Up to approximately 24 months |
| DOR (Duration of Response) | The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first. | Up to approximately 24 months |
| Up to approximately 24 months |
| Neutralizing antibody (Nab) in phaseⅡ | Incidence and titer of Nab of GNC-038 will be evaluated. | Up to approximately 24 months |
| anti-drug antibody (ADA) in phaseⅡ | Frequency and titer of anti-GNC-038 antibody (ADA) will be evaluated. | Up to approximately 24 months |
| Harbin First Hospital | Recruiting | Haerbin | Heilongjing | China |
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| Qingdao Central Hospital | Recruiting | Qingdao | Shandong | China |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |