TT-01488 tablets with rituximab-based treatment for newly diagnosed mantle cell lymphoma

Trial details

Who runs it

TransThera Sciences (Nanjing), Inc.

Trial code

NCT07855016

Record updated

2 October 2026

Original description

This is a multicenter, open-label, phase II study evaluating TT-01488 in combination with different anti-CD20 monoclonal antibody-containing regimens for the treatment of treatment-naïve mantle cell lymphoma (MCL).Read full original descriptionShow less

A Multicenter, Open-Label, Phase II Dose-Exploration and Expansion Study to Evaluate TT-01488 Tablets in Combination With an Anti-CD20 Monoclonal Antibody-Containing Regimen for the Treatment of Mantle Cell Lymphoma.

This is a multicenter, open-label, phase II study evaluating TT-01488 in combination with different anti-CD20 monoclonal antibody-containing regimens for the treatment of treatment-naïve mantle cell lymphoma (MCL).

Inclusion: Combination Cohort A: Part A (dose exploration): Age ≥18 years; no requirement for transplant ineligibility. Part B (efficacy exploration): Age ≥65 years, or 60 to <65 years with ≥1 of the following criteria for autologous stem cell transplantation (auto-SCT) ineligibility:① left ventricular ejection fraction (LVEF) ≤45%;② creatinine clearance (CrCl) 30-<70 mL/min;③ diffusing capacity of the lung for carbon monoxide (DLCO) ≤60% predicted;④ Eastern Cooperative Oncology Group performance status (ECOG PS) 2;⑤ cumulative illness rating scale (CIRS) total score >6;⑥ other comorbidities precluding intensive induction chemotherapy and transplantation, as assessed by the investigator; Combination Cohorts B and C: Age ≥18 years; Histologically confirmed MCL, CD20-positive, with documented high Cyclin D1 expression by immunohistochemistry (IHC) and/or positive t(11;14) by cytogenetics; Ann Arbor clinical stage II-IV; Part A (Dose exploration): ≥1 prior line of therapy, relapsed/refractory disease, no prior BTK inhibitor, and ≤3 total prior lines.Part B (Efficacy exploration): No prior systemic therapy for MCL; At least one measurable lesion; ECOG performance status 0-2; Adequate organ function within 7 days before first dose; Women of childbearing potential: negative pregnancy test before treatment and effective contraception during the study and for 6 months after the last dose; male participants: effective contraception during the same period; Written informed consent obtained before study participation.

Exclusion: Participants whose treatment intent is tumor debulking prior to stem cell transplantation; Severe cardiovascular disease within 6 months prior to screening; History of stroke or intracranial hemorrhage within 6 months before first dose of study drug; History of bleeding diathesis (e.g., hemophilia, von Willebrand disease); requiring or currently receiving anticoagulation with warfarin or equivalent vitamin K antagonists; Requires strong CYP3A4 inhibitors or inducers. Strong CYP3A4 inhibitors within 1 week or strong CYP3A4 inducers within 3 weeks before first dose of study drug are prohibited; Active central nervous system (CNS) involvement by lymphoma, leptomeningeal disease, or history of spinal cord compression; Any active major infection (e.g., bacterial, viral, or fungal), including CMV DNA PCR-positive participants; Serological evidence of active hepatitis B or hepatitis C infection; Known history of human immunodeficiency virus (HIV) infection; Malabsorption syndrome or significant gastrointestinal dysfunction (e.g., gastrectomy, small bowel resection, symptomatic inflammatory bowel disease, complete/incomplete intestinal obstruction); Concurrent or prior malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancers with no disease progression for ≥2 years.

ClinicalTrials.gov NCT07855016