Clinical Trial of TQB2825 in Subjects With CD20 Positive Hematological Tumors (NCT05489276) | Clinical Trial Compass
UnknownPhase 1
Clinical Trial of TQB2825 in Subjects With CD20 Positive Hematological Tumors
China180 participantsStarted 2022-03-22
Plain-language summary
This is a single-group, open, dose escalation and expansion Phase I clinical study, with phase I being a dose escalation study and Phase II being a dose expansion study. The purpose of this study was to evaluate the safety and tolerability of TQB2825 injection in CD20-positive hematological tumor subjects, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) (if any), or optimal biological dose (OBD), and recommended phase II dose (RP2D).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients who have not been alleviated after the last adequate treatment or whose disease has progressed after remission, or who have relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT)
✓. Patients with refractory Anti-CD20 monoclonal antibody.
Exclusion criteria
✕. Hematologic malignancies that have or are suspected to involve the central nervous system (CNS) or primary CNS lymphoma;
✕. Subjects who had or currently had other malignancies within 3 years. Two conditions can be included in clinical trials: five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation; Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)\];
✕. Clinically significant uncontrolled pleural effusion ascites requiring repeated drainage and pericardial effusion with medium or higher volume.
✕. Prior treatment with other antibodies targeting both CD3 and CD20;
✕. Received any investigational antibody drug therapy, CAR T therapy, or other immunocytotherapy, or auto-HSCT within 3 months prior to initial administration;
. The half-life of the first administration is less than 5 drugs from the previous oral targeted therapy (calculated from the end time of the last treatment);