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| Name | Class |
|---|---|
| SystImmune Inc. | INDUSTRY |
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In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in patients with relapsed/refractory hematologic malignancies will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-035.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study treatment | Experimental | Patients receive GNC-035 as a 24-hour continuous intravenous infusion (cIV, QD) for 2 weeks (a 2-week cycle). Participants with no intolerable AEs could continue for another three cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNC-035 | Drug | Administration by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose limiting toxicity | Up to 2 weeks |
| MTD or MAD | Maximum tolerated dose or maximum administrated dose | Up to 2 weeks |
| TEAE | Treatment-Emergent Adverse Event | Up to 2 years |
| The recommended dose for future clinical study | The recommended dose for future clinical study | Up to 2 weeks |
| RP2D | Recommended phase II dose | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| AESI | Adverse Events of special interest | Up to 2 years |
| Cmax | Maximum serum concentration of GNC-035 | Up to 2 weeks |
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Inclusion Criteria:
The participants could understand and sign the informed consent form, and must participate voluntarily
No gender limit
Age: ≥18 and ≤75 years old
Life expectancy estimated to be at least 3 months
Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma, relapsed/refractory chronic lymphocytic leukemia, relapsed/refractory acute B-lymphoblastic leukemia, or relapsed/refractory acute myeloid leukemia
For relapsed or refractory chronic lymphocytic leukemia (CLL/SLL), specifically:
For other patients with relapsed and refractory non-Hodgkin's lymphoma. These include:
Relapsed or refractory acute B-lymphoblastic leukemia, including:
Relapsed/refractory acute myeloid leukemia (AML), relapsed/refractory AML is defined as one of the following:
Patients with Philadelphia chromosome positive (Ph +) acute lymphoblastic leukemia are eligible if they are intolerant or have failed first and/or second generation tyrosine kinase inhibitors (TKIs); patients with a positive T315I mutation do not require TKI salvage
For non-Hodgkin lymphoma, measurable lesions on CT (any lymph node lesion ≥ 1.5 cm in long diameter or > 1.0 cm in long diameter for extranodal lesions) at screening; CLL/SLL: peripheral blood leukemia cells ≥ 5.0 × 109/L; or any lymph node lesion ≥ 1.5 cm in long diameter; WM: IgM 2 × ULN;
For patients with acute lymphoblastic leukemia, ≥ 5% lymphoblasts in the bone marrow by morphologic assessment
For patients with acute myeloid leukemia, ≥ 5% blasts in the bone marrow by morphologic assessment
ECOG Performance Status ≤ 2
Recovery from toxicities of prior anticancer therapy to ≤ Grade 1 as defined by NCI-CTCAEv5.0 (except alopecia)
The organ function level within 7 days before the first administration meets the following requirements:
Bone marrow function (only for patients with non-Hodgkin's lymphoma): Neutrophils without blood transfusion, G-CSF (without long-acting whitening needles within 2 weeks) and drug correction within 7 days before screening Absolute count (ANC) ≥1.0×10^9/L (for subjects with bone marrow infiltration, ≥0.5×10^9/L); hemoglobin ≥80 g/L (for subjects with bone marrow infiltration, ≥70g /L); Platelet count ≥50×10^9/L; Liver function: In the case of no hepatoprotective drugs for correction within 7 days before screening, total bilirubin ≤ 1.5 ULN (Gilbert's syndrome ≤ 3 ULN), transaminase (AST/ALT) ≤ 2.5 ULN (tumor invasive changes in the liver) Subject ≤5.0 ULN), and/or alkaline phosphatase ≤5 ULN; Kidney function: creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (Ccr) ≥ 50 mL/min (calculated by the research center); Coagulation function: fibrinogen ≥ 1.5g/L; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) ≤ 1.5 × ULN;
Female participants with fertility or male participants whose partner(s) are fertile must take effective contraceptive measures from 7 days prior to the first administration to 12 weeks after the administration. Female participants with fertility must have a negative serum/urine pregnancy test in 7 days prior to the first dose.
Subjects are capable and willing to comply with the visits, treatment plans, laboratory examinations and other research-related procedures stipulated in the research protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First People's Hospital | Guangzhou | Guangdong | China | |||
| Affiliated Hospital of Guizhou Medical University |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D012008 | Recurrence |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Tmax | Time to maximum serum concentration (Tmax) of GNC-035 | Up to 2 weeks |
| T1/2 | Half-life of GNC-035 | Up to 2 weeks |
| Incidence and titer of ADA | Anti-drug antibody | Up to 2 years |
| ORR | Objective Response Rate | Up to 2 years |
| DCR | Disease Control Rate | Up to 2 years |
| PFS | Progression-free Survival | Up to 2 years |
| DOR | Duration of Response | Up to 2 years |
| Guiyang |
| Guizhou |
| China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| The Second People's Hospital of Yibin | Yibin | Sichuang | China |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |