NCT07855016

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

StatusNot Yet Recruiting

PhasePhase 2

SponsorTransThera Sciences (Nanjing), Inc.

Primary completionOct 10, 2029 (estimated)

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Record History

All 1 version: 1 with changes below.

Sep 28, 2026 Study First Submitted

Endpoints

Primary

Part A Dose-limiting toxicity (DLT)

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

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

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

Secondary (15)

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

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

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

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

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

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

Part B Best Objective Response Rate (ORR) During Treatment

Part B Best Complete Response Rate (CRR) During Treatment

Part B Time to Response (TTR)

Part B Duration of Response (DOR)

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

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

Part B Safety and Tolerability

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

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

Arms and interventions

Combination Cohort A, Part A dose evaluationExperimental

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

Combination Cohort A, Part B efficacy evaluationExperimental

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

Combination Cohort B, Part A dose evaluationExperimental

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

Combination Cohort B, Part B efficacy evaluationExperimental

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

Experimental: Combination Cohort C, Part A dose evaluationExperimental

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

Experimental: Combination Cohort C, Part B dose evaluationExperimental

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

Drugs: TT-01488 Tablets, Rituximab, Immunomodulatory Agent, BCL2 Inhibitor

Sites

2 sites in 1 country

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).

Trial details

Enrollment: 188 participants (estimated)
Started: Oct 10, 2026
Study completion: Oct 10, 2029 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, non-randomized, open label, treatment
Conditions: Lymphoma, Mantle-Cell, Mantle Cell Lymphoma (MCL)
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.
First posted: Oct 2, 2026
Registry updated: Oct 2, 2026
Last verified: Sep 2026

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