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

ConditionMantle Cell Lymphoma (MCL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTransThera Sciences (Nanjing), Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • TT-01488 Tablets

    Drug

    Oral

  • Rituximab

    Drug

    Intravenous Injection (IV)

  • Immunomodulatory Agent

    Drug

    Oral

  • BCL2 Inhibitor

    Drug

    Oral

Treatment groups

188 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Combination Cohort A, Part A dose evaluationExperimental treatment 2 interventions
Group B: Combination Cohort A, Part B efficacy evaluationExperimental treatment 2 interventions
Group C: Combination Cohort B, Part A dose evaluationExperimental treatment 3 interventions
Group D: Combination Cohort B, Part B efficacy evaluationExperimental treatment 3 interventions
Group E: Experimental: Combination Cohort C, Part A dose evaluationExperimental treatment 3 interventions
Group F: Experimental: Combination Cohort C, Part B dose evaluationExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TransThera Sciences (Nanjing), Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: