Mantle Cell Lymphoma (MCL)Phase 2NCT07855016
A Phase II Study of TT-01488 Tablets in Combination With Anti-CD20 Monoclonal Antibody Therapy in Patients With Mantle Cell Lymphoma
A Phase 2 study testing TT-01488 Tablets, Rituximab and Immunomodulatory Agent in people with Mantle Cell Lymphoma (MCL), run by TransThera Sciences (Nanjing), Inc. at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL)
- What is being tested?
- TT-01488 Tablets, Rituximab and Immunomodulatory Agent
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesChina
- Study dates
- 10 Oct 2026to 10 Oct 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Qingqing Cai, 13798101121, caiqq@sysucc.org.cn
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Rong Tao, 18121293435, hkutao@hotmail.com
About this study
Official title: 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).
Read the detailed description
The study comprises three combination treatment cohorts: Cohort A, TT-01488 plus rituximab; Cohort B, TT-01488 plus rituximab plus an immunomodulatory agent; and Cohort C, TT-01488 plus rituximab plus a BCL2 inhibitor. Each treatment cohort consists of two parts: dose exploration (Part A) and efficacy exploration (Part B). Cohort A will be initiated first. The Safety Monitoring Committee (SMC) will conduct a comprehensive review and assessment based on the safety data from Cohort A, incorporating all available pharmacokinetic (PK) and preliminary efficacy data. Based on the SMC's recommendations, the study team will determine the timing for sequential initiation of Cohorts B and C.
Part A of Cohort A uses a randomized, open-label design. Twelve patients with relapsed or refractory MCL will initially be enrolled and randomized 1:1 to two different TT-01488 tablet dose groups, receiving TT-01488 tablets plus rituximab 375 mg/m². Part B uses a Simon two-stage design, enrolling treatment-naïve MCL patients to receive TT-01488 at the recommended phase 2 dose (RP2D) plus rituximab 375 mg/m².
- Conditions
- Mantle Cell Lymphoma (MCL)
- Being tested
- TT-01488 Tablets, Rituximab, Immunomodulatory Agent, BCL2 Inhibitor
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT-01488 TabletsDrug
Oral
RituximabDrug
Intravenous Injection (IV)
Immunomodulatory AgentDrug
Oral
BCL2 InhibitorDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TT-01488 Tablets; Drug: Rituximab |
| Combination Cohort A, Part B efficacy evaluation | Experimental | Participants with treatment-naive mantle cell lymphoma (MCL). Receives: 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. Receives: 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). Receives: 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. Receives: 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). Receives: Drug: TT-01488 Tablets; Drug: Rituximab; Drug: BCL2 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Dose-limiting toxicity (DLT)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Part B Complete Response Rate (CRR) After 6 Cycles of Induction Therapy
Measured: After 6 cycles of induction therapy (each cycle is 28 days)
Secondary outcomes (15)
Part A Maximum Plasma Concentration (Cmax) of TT-01488
Measured: Up to 60 months
Part A Time to Reach Maximum Plasma Concentration (Tmax) of TT-01488
Measured: Up to 60 months
Part A Terminal Half-Life (t1/2) of TT-01488
Measured: Up to 60 months
Part A Area Under the Plasma Concentration-Time Curve During the Dosing Interval (AUCtau) of TT-01488
Measured: Up to 60 months
Part A Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC0-t) of TT-01488
Measured: Up to 60 months
Part B Objective Response Rate (ORR) After 6 cycles of induction therapy
Measured: After 6 cycles of induction therapy (each cycle is 28 days)
Part B Best Objective Response Rate (ORR) During Treatment
Measured: Up to 60 months
Part B Best Complete Response Rate (CRR) During Treatment
Measured: Up to 60 months
Part B Time to Response (TTR)
Measured: Up to 60 months
Part B Duration of Response (DOR)
Measured: Up to 60 months
Part B PFS rates at 12, 24, 36, 48, and 60 months
Measured: Up to 60 months
Part B OS rates at 12, 24, 36, 48, and 60 months
Measured: Up to 60 months
Part B Safety and Tolerability
Measured: Up to 60 months
PartＢChange From Baseline in EQ-5D-5L Utility Index Score
Measured: Up to 60 months
Part B Change From Baseline in Global Health Status/Quality of Life Using the EORTC QLQ-C30
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2029 (estimated)
- Study completion10 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855016
- Sponsor's protocol ID
- TT01488CN03
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No