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

NCT07855016 | Not Yet Recruiting Phase 2

• 1 other identifier: TT01488CN03
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Mantle Cell Lymphoma (MCL)

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (15)

• Part A Maximum Plasma Concentration (Cmax) of TT-01488

  Up to 60 months

• Part A Time to Reach Maximum Plasma Concentration (Tmax) of TT-01488

  Up to 60 months

• Part A Terminal Half-Life (t1/2) of TT-01488

  Up to 60 months

• Part A Area Under the Plasma Concentration-Time Curve During the Dosing Interval (AUCtau) of TT-01488

  Up to 60 months

• Part A Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC0-t) of TT-01488

  Up to 60 months

Study Arms (6)

Combination Cohort A, Part A dose evaluation

EXPERIMENTAL

Combination dose evaluation and RP2D determination ; Two dose levels of TT-01488 to be evaluated; R/R MCL participants will be enrolled.

Drug: TT-01488 Tablets; Drug: Rituximab

Combination Cohort A, Part B efficacy evaluation

EXPERIMENTAL

Participants with treatment-naive mantle cell lymphoma (MCL).

Drug: TT-01488 Tablets; Drug: Rituximab

Combination Cohort B, Part A dose evaluation

EXPERIMENTAL

Combination dose evaluation and RP2D determination; R/R MCL participants will be enrolled.

Drug: TT-01488 Tablets; Drug: Rituximab; Drug: Immunomodulatory Agent

Combination Cohort B, Part B efficacy evaluation

EXPERIMENTAL

Participants with treatment-naive mantle cell lymphoma (MCL).

Drug: TT-01488 Tablets; Drug: Rituximab; Drug: Immunomodulatory Agent

Experimental: Combination Cohort C, Part A dose evaluation

EXPERIMENTAL

Combination dose evaluation and RP2D determination; R/R MCL participants will be enrolled.

Drug: TT-01488 Tablets; Drug: Rituximab; Drug: BCL2 Inhibitor

Experimental: Combination Cohort C, Part B dose evaluation

EXPERIMENTAL

Participants with treatment-naive mantle cell lymphoma (MCL).

Drug: TT-01488 Tablets; Drug: Rituximab; Drug: BCL2 Inhibitor

Interventions

TT-01488 Tablets DRUG

Oral

Combination Cohort A, Part A dose evaluation; Combination Cohort A, Part B efficacy evaluation; Combination Cohort B, Part A dose evaluation; Combination Cohort B, Part B efficacy evaluation; Experimental: Combination Cohort C, Part A dose evaluation; Experimental: Combination Cohort C, Part B dose evaluation

Rituximab DRUG

Intravenous Injection (IV)

Combination Cohort A, Part A dose evaluation; Combination Cohort A, Part B efficacy evaluation; Combination Cohort B, Part A dose evaluation; Combination Cohort B, Part B efficacy evaluation; Experimental: Combination Cohort C, Part A dose evaluation; Experimental: Combination Cohort C, Part B dose evaluation

Immunomodulatory Agent DRUG

Oral

Combination Cohort B, Part A dose evaluation; Combination Cohort B, Part B efficacy evaluation

BCL2 Inhibitor DRUG

Oral

Experimental: Combination Cohort C, Part A dose evaluation; Experimental: Combination Cohort C, Part B dose evaluation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• TransThera Sciences (Nanjing), Inc.: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Rituximab; Adjuvants, Immunologic; PTH2 protein, human

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Caixia Sun

CONTACT

025-58216298; clinicaltrial@transtherabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): October 10, 2029
• Study Completion (Estimated): October 10, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)