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Starting soon Phase 2

A Phase II Study of TT-01488 Tablets in Combination With Anti-CD20 Monoclonal Antibody Therapy in Patients With Mantle Cell Lymphoma

NCT07855016 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-10-10
Last updated
2026-10-02

Condition(s) studied

Mantle Cell Lymphoma (MCL)

Investigational drug(s) / intervention(s)

TT-01488 Tablets →Rituximab →Immunomodulatory AgentBCL2 Inhibitor

TT-01488 Tablets: Oral

Rituximab: Intravenous Injection (IV)

Immunomodulatory Agent: Oral

BCL2 Inhibitor: Oral

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Participants whose treatment intent is tumor debulking prior to stem cell transplantation; * Active central nervous system (CNS) involvement by lymphoma, leptomeningeal disease, or history of spinal cord compression; * Severe cardiovascular disease within 6 months prior to screening; * 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; * 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; * 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; * Malabsorption syndrome or significant gastrointestinal dysfunction (e.g., gastrectomy, small bowel resection, symptomatic inflammatory bowel disease, complete/incomplete intestinal obstruction).

Primary outcome measure(s)

  • Part A Dose-limiting toxicity (DLT) — At the end of Cycle 1 (each cycle is 28 days)
  • Part B Complete Response Rate (CRR) After 6 Cycles of Induction Therapy — After 6 cycles of induction therapy (each cycle is 28 days)

Trial sites (2)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07855016 on ClinicalTrials.gov ↗ ← All trials in China