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| Name | Class |
|---|---|
| SystImmune Inc. | INDUSTRY |
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An open, multicenter, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics, and antitumor activity of GNC-038 quad-specific antibody injection in relapsed or refractory non-Hodgkin's lymphoma, relapsed or refractory acute lymphoblastic leukemia, and refractory or metastatic solid tumors.
Phase Ia: To observe the safety and tolerability of GNC-038 in patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL)/relapsed or refractory acute lymphoblastic leukemia (R/R ALL), To determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and dose-limiting toxicity (DLT) of GNC-038 without MTD and recommend the dose for subsequent clinical studies. Phase Ib: To further observe the safety and tolerability of GNC-038 at the Phase Ia recommended dose to determine the Phase II recommended dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment | Experimental | The patients received intravenous infusion of GNC-038 for 1 cycle. After the completion of 2 cycles of treatment, participants with no unbearable ae could proceed to the 3rd and 4th cycles of treatment. After four cycles of treatment, participants with clinical benefits could also receive four additional cycles of the same dose. |
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| 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 administrated 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 |
| Treatment-Emergent Adverse Event (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 |
| The recommended dose for future clinical study | 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 of GNC-038 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of GNC-038 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang | Hematology Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Junyuan Qi | Hematology Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| Peking University Third Hospital |
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Maximum serum concentration (Cmax) of GNC-038 will be investigated.
| Up to 14 days after the first dose of GNC-038 |
| Css: Concentration of GNC-038 at steady state plateau | Concentration of GNC-038 at steady state plateau will be investigated. | Up to 14 days after the first dose of GNC-038 |
| Tmax: Time to maximum serum concentration (Tmax) of GNC-038 | Time to maximum serum concentration (Tmax) of GNC-038 will be investigated. | Up to 14 days after the first dose of GNC-038 |
| T1/2: Half-life of GNC-038 | Half-life (T1/2) of GNC-038 will be investigated. | Up to 14 days after the first dose of GNC-038 |
| AUC0-inf: Area under the serum concentration-time curve from time 0 to infinity | Blood concentration - Area under time line. | Up to 14 days after the first dose of GNC-038 |
| AUC0-t: Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration | Blood concentration - Area under time line. | Up to 14 days after the first dose of GNC-038 |
| CL: Clearance in the serum of GNC-038 per unit of time | To study the serum clearance rate of GNC-038 per unit time. | Up to 14 days after the first dose of GNC-038 |
| Incidence and titer of ADA (Anti-drug antibody) | Frequency and titer of anti-GNC-038 antibody (ADA) will be evaluated. | Up to approximately 24 months |
| Incidence and titer of Nab (Neutralizing antibody) | Incidence and titer of Nab of GNC-038 will be evaluated. | Up to approximately 24 months |
| ORR (Objective Response Rate ) | ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1. | Up to approximately 24 months |
| DCR (Disease Control Rate) | The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). | Up to approximately 24 months |
| PFS (Progression-free Survival) | 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 |
| 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 |
| Beijing |
| Beijing Municipality |
| China |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| Shanghai Tongji Hospital | Shanghai | Shanghai Municipality | China |
| Hematology Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300000 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
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