A Study of GNC-035, a Tetra-specific Antibody, in Participants With Relapsed/Refractory Hematolog… (NCT05104775) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of GNC-035, a Tetra-specific Antibody, in Participants With Relapsed/Refractory Hematologic Malignancy
China33 participantsStarted 2022-02-09
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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:
Exclusion criteria
✕. Patients who have undergone major surgery within 28 days prior to dosing in this study, or are scheduled to undergo major surgery during this study ("major surgery"is defined by the investigator)
✕. Pulmonary disease ≥ grade 3 according to NCI-CTCAEv5.0: including resting dyspnea, or requiring continuous oxygen therapy; patients with current interstitial lung disease (ILD) (except for those with previous interstitial pneumonia)
✕. Systemic serious infections occurred within 4 weeks before screening，including but not limited to severe pneumonia, bacteremia or serious infectious complications caused by fungi, bacteria and viruses
✕. Patients with active autoimmune diseases, or patients with a history of autoimmune diseases
✕. Patients complicated with other malignant tumors within 5 years before the first dose, and cured non-melanoma in situ skin cancer, superficial bladder cancer, in situ cervical cancer, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer and other cancers that are considered by the investigator to be eligible
✕. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (positive HBsAg or positive HBcAb with HBV-DNA ≥ ULN), or hepatitis C virus infection (positive HCV antibody with HCV-RNA ≥ ULN)
✕. Hypertension poorly controlled on medication (systolic \> 150 mmHg or diastolic \> 100 mmHg)
✕. Left ventricular ejection fraction ≤ 45%, or history of significant cardiac disease within 1 year