Evaluating HH2853 for treating relapsed peripheral T-cell lymphoma

An Open-label, Multinational, Multicenter, Single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853, a Selective EZH1/2 Inhibitor, in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma

This study is testing a new oral medication called HH2853 to see if it can help people with relapsed peripheral T-cell lymphoma feel better after other treatments have failed.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Haihe Biopharma Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chengdu, Chengdu)
• Trial ID: NCT06909877 on ClinicalTrials.gov

What this trial studies

This study is an open-label, multinational, multicenter, single-arm Phase Ib/II evaluation of the efficacy and safety of oral HH2853 in patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL). The Phase Ib component focuses on dose escalation and expansion for patients who have received prior treatments, while the Phase II component will enroll patients who have undergone at least one systemic chemotherapy and one new drug therapy. The study aims to determine the recommended Phase 2 dose (RP2D) and assess the safety, tolerability, and pharmacokinetic profile of HH2853. Approximately 21-48 patients will be enrolled in Phase Ib, and around 66 patients in Phase II.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed relapsed or refractory peripheral T-cell lymphoma who have received at least one prior systemic treatment.

Not a fit: Patients with highly invasive T-cell lymphomas or those who have not received prior systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory peripheral T-cell lymphoma.

How similar studies have performed: Other studies have shown promise in treating relapsed/refractory lymphomas with novel agents, but the specific approach with HH2853 is relatively novel.

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.

Where this trial is running

Chengdu, Chengdu

• Sichuan Cancer Hospital — Chengdu, Chengdu, China (Recruiting)

Study contacts

• Principal investigator: Tongyu Li, MD — Sichuan Cancer Hospital and Research Institute
• Study coordinator: Haiying Jia

Conditions Relapsed/Refractory Peripheral T-Cell Lymphoma; Relapsed/Refractory; Peripheral T-cell Lymphoma