Evaluating HH2853 for treating relapsed peripheral T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sichuan Cancer Hospital
  Chengdu, Chengdu, China Recruiting

Study contacts

• Principal investigator: Tongyu Li, MD — Sichuan Cancer Hospital and Research Institute
• Study coordinator: Haiying Jia
• Email: haiying.jia@haihepharma.com
• Phone: 86-20568888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.