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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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.

Caixia Sun contact

025-58216298

clinicaltrial@transtherabio.com

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

Other trials in China

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.

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 groups in NCT07855016
Study groupRoleWhat they receive
Combination Cohort A, Part A dose evaluationExperimentalCombination 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 evaluationExperimentalParticipants with treatment-naive mantle cell lymphoma (MCL).
Receives: Drug: TT-01488 Tablets; Drug: Rituximab
Combination Cohort B, Part A dose evaluationExperimentalCombination 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 evaluationExperimentalParticipants with treatment-naive mantle cell lymphoma (MCL).
Receives: Drug: TT-01488 Tablets; Drug: Rituximab; Drug: Immunomodulatory Agent
Experimental: Combination Cohort C, Part A dose evaluationExperimentalCombination 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 evaluationExperimentalParticipants 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.

  1. Part A Dose-limiting toxicity (DLT)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. 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)

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

    Measured: Up to 60 months

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

    Measured: Up to 60 months

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

    Measured: Up to 60 months

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

    Measured: Up to 60 months

  5. 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

  6. Part B Objective Response Rate (ORR) After 6 cycles of induction therapy

    Measured: After 6 cycles of induction therapy (each cycle is 28 days)

  7. Part B Best Objective Response Rate (ORR) During Treatment

    Measured: Up to 60 months

  8. Part B Best Complete Response Rate (CRR) During Treatment

    Measured: Up to 60 months

  9. Part B Time to Response (TTR)

    Measured: Up to 60 months

  10. Part B Duration of Response (DOR)

    Measured: Up to 60 months

  11. Part B PFS rates at 12, 24, 36, 48, and 60 months

    Measured: Up to 60 months

  12. Part B OS rates at 12, 24, 36, 48, and 60 months

    Measured: Up to 60 months

  13. Part B Safety and Tolerability

    Measured: Up to 60 months

  14. PartＢChange From Baseline in EQ-5D-5L Utility Index Score

    Measured: Up to 60 months

  15. 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.

  1. First posted2 Oct 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion10 Oct 2029 (estimated)
  4. Study completion10 Oct 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caixia Sun (025-58216298, clinicaltrial@transtherabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A Dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07855016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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