Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma

Launched by HAIHE BIOPHARMA CO., LTD. · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called HH2853 for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), which is a type of cancer that affects the lymphatic system. The trial is currently recruiting participants who have already received treatment for their cancer but have not responded well or have experienced a relapse. To be eligible, patients should have a confirmed diagnosis of PTCL and have received at least one prior treatment. They also need to have good overall health, as indicated by a specific scoring system, and a life expectancy of at least three months.

Participants in this study will take HH2853 and will be monitored for how well it works and whether it is safe. The trial is open to patients of all genders and ages between 65 and 93. It's important to note that individuals with certain previous treatments or specific health conditions may not be eligible to join. Overall, this trial aims to find a potentially effective treatment option for those struggling with this challenging type of lymphoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * main inclusion:
• • 1. Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolled patients must have histologically confirmed diagnosis NHL who have received at least one line of prior systematic treatment (and ≤ 5 lines) and relapses or refractory. Phase Ib dose expansion part: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL), monomorphic epitheliotropic internal T-cell lymphoma (MEITL), Hepatosplenic T-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheral T-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cell sources NHL at the investigator and sponsor's discretion (except highly invasive). All enrolled patients had relapsed or refractory diseases after receiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL, Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis of R/R PTCL who have received at least one line of prior systematic combination chemotherapy and at least one new drug therapy (prior antitumor treatment lines ≤4 lines) : relapse and/or refractory.
• • 2. Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.
• • 3. The Eastern cooperative oncology group (ECOG) score 0-1.
• • 4. Life expectancy ≥ 3 months before starting HH2853 treatment.
• • 5. Sufficient bone marrow, liver and renal functions.
• Exclusion Criteria:
• * main criteria:
• • 1. Previous treatment with EZH2 or EZH1/2 inhibitors.
• • 2. Central nervous system invasion.
• • 3. Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).
• • 4. Received medications that are known potent CYP3A4 inducers/inhibitors within 1 week prior to first dose.