A Study of GNC-035 in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological… (NCT05944978) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of GNC-035 in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies
China3 participantsStarted 2023-08-16
Plain-language summary
An open-label, multicenter, phase Ib/II clinical trial was conducted to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of GNC-035 quad-specific antibody injection in patients with relapsed or refractory chronic lymphocytic leukemia and other hematological malignancies
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form;
✓. No gender limit;
✓. Age: ≥18 years old (≤75 years old for climbing);
✓. expected survival time ≥3 months;
✓. Patients with hematological malignancies such as relapsed/refractory chronic lymphocytic leukemia confirmed by histology or cytology;
✓. For relapsed or refractory chronic lymphocytic leukemia (CLL/SLL), specifically:
✓. For other patients with relapsed refractory non-Hodgkin lymphoma. These include:
✓. CLL/SLL: peripheral blood leukemia cells ≥5.0×109/L; Or the long diameter of any lymph node lesion ≥1.5cm; Patients with non-Hodgkin's lymphoma had measurable disease at screening (nodal disease ≥1.5cm in the greatest dimension or extranodal disease \> 1.0cm in the greatest dimension).
Exclusion criteria
✕. Patients who underwent major surgery within 28 days before study administration or who were scheduled to undergo major surgery during the study (" major surgery "was defined by the investigator);
✕. Pulmonary disease grade ≥3 according to NCI-CTCAE v5.0, including dyspnea at rest or requiring continuous oxygen therapy; Patients with current interstitial lung disease (ILD) (except those who have recovered from previous interstitial pneumonia);
. Severe systemic infection occurred within 4 weeks before screening, including but not limited to severe pneumonia caused by fungi, bacteria, or viruses, bacteremia, or serious infectious complications;
✕. Patients with active autoimmune disease or a history of autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism that is stable with hormone-replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis, or vitiligo that does not require systemic therapy, as deemed by the investigators, were excluded.
✕. Patients with other malignant tumors within 3 years before the first drug administration, cured non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal mucosal cancer, breast cancer, localized prostate cancer, and other patients without recurrence within 3 years were excluded.
✕. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive and HBV-DNA test ≥ central detection lower limit) or hepatitis C virus infection (HCV antibody positive and HCV-RNA≥ central detection lower limit);
✕. Hypertension poorly controlled by medication (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
✕. Left ventricular ejection fraction ≤45%, or history of major heart disease within 1 year: