A Study of BEBT-908 in Combination With Chemotherapy in Patients With Previously Untreated Peripheral T-Cell Lymphoma (PTCL)

NCT07676175 | Not Yet Recruiting Phase 2

• 1 other identifier: GBMT-908-P10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical study is to find the best way to combine the study drug BEBT-908 (ifupinostat hydrochloride for injection) with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for treating previously untreated peripheral T-cell lymphoma, and to find out whether this best combination is better than standard CHOP treatment alone. The main questions this study will try to answer are: What percentage of participants will respond well to treatment with BEBT-908 plus CHOP? Is BEBT-908 plus CHOP better than standard CHOP treatment? What medical problems will participants have while receiving this combination treatment? This study includes an Exploration Phase and an Expansion Phase. The Exploration Phase has 3 cohorts. All participants receive both BEBT-908 and CHOP, but the dosing arrangements differ across cohorts: the dose of BEBT-908 differs, the sequencing of administration differs, and whether participants continue with CHOP or transition to BEBT-908 depends on their tolerability to CHOP. Eligible participants will receive the combination treatment for their assigned cohort. After that, based on the results from all 3 cohorts in the Exploration Phase, one optimal cohort will be selected to proceed into the Expansion Phase. In the Expansion Phase, eligible participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to either the treatment group, receiving the optimal combination regimen identified in the Exploration Phase, or the control group, receiving 6 cycles of CHOP. This study design will help investigators find the best way to combine BEBT-908 and CHOP for treating previously untreated peripheral T-cell lymphoma, and check whether this optimal combination regimen is better than standard CHOP treatment.

Conditions

Previously Untreated Peripheral T-Cell Lymphoma

Keywords

BEBT-908; PTCL; Safety; Pharmacokinetics; Efficacy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The percentage of all participants who have a complete response (CR) or partial response (PR).

  Up to 24 months

Secondary Outcomes (19)

• Complete Response Rate (CRR)

  Up to 24 months

• Event-Free Survival (EFS)

  Up to 24 months

• Disease Control Rate (DCR)

  Up to 24 months

• Time to Response (TTR)

  Up to 24 months

• Time to Progression (TTP)

  Up to 24 months

Other Outcomes (1)

• Biomarker Research

  Up to 24 months

Study Arms (4)

Cohort 1 (Exploration Phase)

EXPERIMENTAL

BEBT-908 (8.2 mg/m²) administered together with CHOP for 6 cycles. After cycle 6, participants without progressive disease ( PD) may continue receiving BEBT-908 (18.5 mg/m²) and enter a maintenance treatment phase for up to 24 months.

Drug: Ifupinostat Hydrochloride for Injection; Drug: Cyclophosphamide for Injection; Drug: Doxorubicin Hydrochloride for Injection; Drug: Vincristine Sulfate for Injection; Drug: Prednisone Acetate Tablets

Cohort 2 (Exploration Phase)

EXPERIMENTAL

CHOP for 2 cycles, then BEBT-908 (18.5 mg/m²) for 4 cycles, then CHOP for 4 cycles. After cycle 10, participants without progressive disease (PD) may continue receiving BEBT-908 (18.5 mg/m²) and enter a maintenance treatment phase for up to 24 months.

Drug: Ifupinostat Hydrochloride for Injection; Drug: Cyclophosphamide for Injection; Drug: Doxorubicin Hydrochloride for Injection; Drug: Vincristine Sulfate for Injection; Drug: Prednisone Acetate Tablets

Cohort 3 (Exploration Phase)

EXPERIMENTAL

BEBT-908 (18.5 mg/m²) for 4 cycles, then either CHOP for 2-6 cycles or BEBT-908 (18.5 mg/m²) for 4 more cycles. After that: For participants who are intolerant to CHOP chemotherapy: after cycle 8, participants without progressive disease (PD) may continue receiving BEBT-908 (18.5 mg/m²) and enter a maintenance treatment phase for up to 24 months. For participants who are tolerant to CHOP chemotherapy: after their CHOP treatment ends, participants without progressive disease (PD) may continue receiving BEBT-908 (18.5 mg/m²) and enter a maintenance treatment phase for up to 24 months.

Drug: Ifupinostat Hydrochloride for Injection; Drug: Cyclophosphamide for Injection; Drug: Doxorubicin Hydrochloride for Injection; Drug: Vincristine Sulfate for Injection; Drug: Prednisone Acetate Tablets

CHOP (Expansion Phase)

ACTIVE COMPARATOR

The CHOP chemotherapy regimen will be administered for a total of 6 cycles.

Drug: Cyclophosphamide for Injection; Drug: Doxorubicin Hydrochloride for Injection; Drug: Vincristine Sulfate for Injection; Drug: Prednisone Acetate Tablets

Interventions

Ifupinostat Hydrochloride for Injection DRUG

Administered by intravenous infusion at a dose of 8.2 mg/m² or 18.5 mg/m². It is administered on days 1, 3, 5, 8, 10, and 12 of each cycle. Each cycle lasts 21 days.

Also known as: BEBT-908

Cohort 1 (Exploration Phase); Cohort 2 (Exploration Phase); Cohort 3 (Exploration Phase)

Cyclophosphamide for Injection DRUG

Administered by intravenous infusion at a dose of 750 mg/m². It is administered on day 1 of each cycle. Each cycle lasts 21 days.

Also known as: Endoxan

CHOP (Expansion Phase); Cohort 1 (Exploration Phase); Cohort 2 (Exploration Phase); Cohort 3 (Exploration Phase)

Doxorubicin Hydrochloride for Injection DRUG

Administered by intravenous infusion at a dose of 50 mg/m². It is administered on day 1 of each cycle. Each cycle lasts 21 days.

Also known as: Adriamycin

CHOP (Expansion Phase); Cohort 1 (Exploration Phase); Cohort 2 (Exploration Phase); Cohort 3 (Exploration Phase)

Vincristine Sulfate for Injection DRUG

Administered by intravenous infusion at a dose of 1.4 mg/m² (maximum dose of 2 mg). It is administered on day 1 of each cycle. Each cycle lasts 21 days.

Also known as: Leurocristine

CHOP (Expansion Phase); Cohort 1 (Exploration Phase); Cohort 2 (Exploration Phase); Cohort 3 (Exploration Phase)

Prednisone Acetate Tablets DRUG

Administered by mouth at a dose of 100 mg. It is administered on days 1 through 5 of each cycle. Each cycle lasts 21 days.

Also known as: Deltasone

CHOP (Expansion Phase); Cohort 1 (Exploration Phase); Cohort 2 (Exploration Phase); Cohort 3 (Exploration Phase)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must fully understand the study and voluntarily sign an informed consent form (ICF).
• Age 18 to 75 years (inclusive), either sex.
• Histologically confirmed peripheral T-cell lymphoma (PTCL), including not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) deemed by the investigator to be ineligible for or unable to receive anti-CD30 monoclonal antibody therapy (e.g., brentuximab vedotin) due to economic burden or intolerable toxicity (if ALK-positive, International Prognostic Index \[IPI\] score must be ≥2), subcutaneous panniculitis-like T-cell lymphoma (SPTCL), enteropathy-associated T-cell lymphoma (EATL), hepatosplenic T-cell lymphoma (HSTL), and other T-cell lymphomas deemed appropriate for enrollment by the investigator.
• No prior systemic anti-PTCL therapy.
• Life expectancy \>6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• At least one measurable and evaluable tumor lesion (per Lugano 2014 criteria: nodal lesions must have a longest diameter \>1.5 cm; extranodal lesions must have a longest diameter \>1.0 cm).
• At screening, laboratory parameters must meet the following standards, unless the investigator determines the abnormality is due to lymphoma (with no corrective or supportive treatment for the following parameters within 2 weeks prior to assessment):
• Peripheral Blood: a) Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L (≥1.0×10⁹/L for patients with bone marrow involvement); b) White Blood Cell count (WBC) ≥3.0×10⁹/L (≥2.0×10⁹/L for patients with bone marrow involvement); c) Hemoglobin (HGB) ≥80 g/L; d) Platelet count (PLT) ≥75×10⁹/L (≥50×10⁹/L for patients with bone marrow involvement).
• Hepatic and Renal Function: a) Serum total bilirubin ≤1.5×Upper Limit of Normal (ULN) (≤3.0×ULN for patients with liver involvement); b) Serum creatinine \<1.5×ULN; c) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×ULN, or ≤5×ULN if the investigator determines the elevation is due to hepatic infiltration.

You may not qualify if:

• History or current diagnosis of immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, or other primary or secondary hematologic disorders that may affect bone marrow function, other than the primary malignancy.
• Receipt of transfusion, recombinant human thrombopoietin (rhTPO), erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or similar treatments within 2 weeks prior to the first dose of study drug.
• Active bleeding within 2 months prior to the first dose, or current use of anticoagulant medications (e.g., warfarin, phenprocoumon), or evidence of a clear bleeding tendency as determined by the investigator (e.g., esophageal varices at risk of bleeding, active localized ulcerative lesions, fecal occult blood \>2+), except for bleeding attributed by the investigator to lymphoma itself (e.g., gastrointestinal bleeding caused by gastrointestinal lymphoma).
• Participation in another interventional clinical trial within 3 months prior to the first dose.
• PTCL with involvement of special sites such as testis, breast, or ovary; extranodal natural killer/T-cell lymphoma (ENKTL); cutaneous T-cell lymphoma (except subcutaneous panniculitis-like T-cell lymphoma \[SPTCL\]); or concurrent hemophagocytic lymphohistiocytosis (HLH).
• Receipt of the following treatments within 7 days prior to study entry: drugs known to be strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, or drugs known to significantly prolong the QT interval.
• Major surgery requiring general anesthesia within 4 weeks prior to enrollment, or surgery requiring local/epidural anesthesia within 2 weeks prior to enrollment with incomplete recovery (excluding bone marrow biopsy or local lymphoid tissue biopsy).
• Active infection requiring systemic treatment (oral or intravenous) within 2 weeks prior to the first dose, or imaging findings suggestive of interstitial lung disease (ILD), pulmonary fibrosis, or pneumonia (infectious or non-infectious) requiring treatment: participants receiving prophylactic antibiotic therapy (e.g., for interstitial pneumonia) are eligible for enrollment; participants with patchy changes from old or previously treated lesions, determined by the investigator to not affect lung function and not require treatment, are eligible for enrollment.
• Corticosteroid use \>30 mg/day prednisone or equivalent for purposes other than lymphoma symptom control; the following permitted scenarios must meet corresponding requirements:
• If currently receiving corticosteroid therapy at ≤30 mg/day prednisone or equivalent, documented evidence of stable dosing for at least 4 weeks prior to initiation of study drug is required.
• If urgent corticosteroid therapy is needed prior to the first dose to control lymphoma symptoms, prednisone up to 100 mg/day or equivalent may be used for a maximum of 7 days; however, all tumor assessments must be completed before initiation of corticosteroid therapy.
• Mean corrected QT interval (QTc) \>450 msec (male) or \>470 msec (female) derived from 3 electrocardiogram (ECG) recordings at rest (repeat testing and averaging of 3 corrected values is required only when the first ECG indicates QTc \>450 msec \[male\] or \>470 msec \[female\]); history of long QT syndrome or confirmed family history of long QT syndrome; history of clinically significant ventricular arrhythmia, or current use of antiarrhythmic drugs or implanted defibrillator for treatment of ventricular arrhythmia.
• Inability to discontinue during the study period medications that may cause QT prolongation (e.g., antiarrhythmic drugs).
• Tumor invasion of surrounding vital organs or vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava) with risk of bleeding, or risk of esophagotracheal fistula or esophagopleural fistula.
• Participants with clinically symptomatic pleural effusion, ascites, or pericardial effusion that remains poorly controlled despite repeated treatment.

Sponsors & Collaborators

• BeBetter Med Inc: lead
• Sun Yat-Sen University Cancer Center: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510050, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Interventions

Injections; BEBT-908; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Kegang Jiang, Master

CONTACT

+86-18664786382; kjiang@bebettermed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (3)