CClinicalTrials.gg
Sign In
Not yet recruitingNCT07855016Updated Oct 2, 2026

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 interventional study of TT-01488 Tablets and Rituximab in Mantle Cell Lymphoma (MCL), sponsored by TransThera Sciences (Nanjing), Inc.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by TransThera Sciences (Nanjing), Inc. · Phase 2, Interventional, and Treatment

Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
188
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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).

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.

02

Conditions studied

  • Mantle Cell Lymphoma (MCL)

Browse trials for

03

In context

Lymphoma, Mantle-Cell

783 studies on the registry are indexed under Lymphoma, Mantle-Cell; 146 are open to participants now.

This study's planned enrollment of 188 is above the median of 39 across 699 interventional studies indexed under Lymphoma, Mantle-Cell.

Browse Lymphoma, Mantle-Cell studies →

Lead sponsor

TransThera Sciences (Nanjing), Inc. is the lead sponsor of 18 studies on the registry; 6 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
188 participants (estimated)

Study arms

  • Experimental
    Combination Cohort A, Part A dose evaluation

    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

  • Experimental
    Combination Cohort A, Part B efficacy evaluation

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

    Drug: TT-01488 Tablets · Drug: Rituximab

  • Experimental
    Combination Cohort B, Part A dose evaluation

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

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

  • Experimental
    Combination Cohort B, Part B efficacy evaluation

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

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

  • Experimental
    Experimental: Combination Cohort C, Part A dose evaluation

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

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

  • Experimental
    Experimental: Combination Cohort C, Part B dose evaluation

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

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

Interventions

  • DrugTT-01488 Tablets

    Oral

  • DrugRituximab

    Intravenous Injection (IV)

  • DrugImmunomodulatory Agent

    Oral

  • DrugBCL2 Inhibitor

    Oral

06

What researchers measure

Primary outcomes

  1. Part A Dose-limiting toxicity (DLT)

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

  2. Part B Complete Response Rate (CRR) After 6 Cycles of Induction Therapy

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

Secondary outcomes

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

    Time frame: Up to 60 months

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

    Time frame: Up to 60 months

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

    Time frame: Up to 60 months

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

    Time frame: 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

    Time frame: Up to 60 months

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

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

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

    Time frame: Up to 60 months

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

    Time frame: Up to 60 months

  9. Part B Time to Response (TTR)

    Time frame: Up to 60 months

  10. Part B Duration of Response (DOR)

    Time frame: Up to 60 months

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

    Time frame: Up to 60 months

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

    Time frame: Up to 60 months

  13. Part B Safety and Tolerability

    Time frame: Up to 60 months

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

    Time frame: Up to 60 months

  15. Part B Change From Baseline in Global Health Status/Quality of Life Using the EORTC QLQ-C30

    Time frame: Up to 60 months

07

Study locations

2 sites
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510000, China
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07855016
Lead sponsor
TransThera Sciences (Nanjing), Inc.
Responsible party
Sponsor
First posted
Oct 2, 2026
Start date
Oct 10, 2026 (estimated)
Primary completion
Oct 10, 2029 (estimated)
Completion
Oct 10, 2029 (estimated)
Last update
Oct 2, 2026

Study contacts

Caixia Sun
Contact
clinicaltrial@transtherabio.com
025-58216298

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma, Mantle-Cell→

Other studies from this sponsor

TransThera Sciences (Nanjing), Inc.

Start the discussion