NCT06909877

Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory 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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma.

Detailed description

This study includes Phase Ib and Phase II. In the Phase Ib, patients with R/R NHL (dose escalation) or R/R PTCL (dose expansion) who have received at least 1 line of prior systematic treatment and meet the inclusion/exclusion criteria in the protocol will be enrolled. Safety run-in study (Japan only): The objective of the safety run-in study in Japan is to evaluate the safety, tolerability, and PK profile of HH2853 in Japanese patients. The primary objective of the Phase Ib study is to determine the RP2D of HH2853 in PTCL patients. The secondary objectives are to evaluate the safety, preliminary efficacy and characterize the pharmacokinetic profile of HH2853 in R/R PTCL patients. A "3+3" design will be used in the dose escalation part with a starting dose of 400 mg BID. Based on the safety, efficacy and PK/PD data and HH2853-G101 data, 1-2 dose levels could be expanded, 10-15 R/R PTCL patients for each dose level. Approximately 21-48 patients will be enrolled in total. In the Phase II (multi-national): patients with R/R PTCL who have received at least one prior systemic combination chemotherapy and at least one new drug therapy and meet the inclusion/exclusion criteria in the protocol will be enrolled. The Phase II study will be started once the RP2D is determined. The Phase II study is a single-arm study and will be enrolled in approximately 66 efficacy-evaluable R/R PTCL patients who had received at least one prior systemic combination chemotherapy and at least one new drug therapy. The primary objective of the Phase II study is to evaluate the efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug therapy (ORR, BIRC evaluation); The secondary objectives will be continued to further evaluate the efficacy, safety, tolerability and PK characteristics of HH2853 of R/R PTCL patients who have received at least 1 line of prior systemic therapy.

Conditions

• Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

Interventions

Type	Name	Description
DRUG	HH2853 Tablets	25mg, 100mg and 200 mg BID oral administration

Timeline

• Start date: 2022-07-27
• Primary completion: 2025-10-31
• Completion: 2027-07-30
• First posted: 2025-04-04
• Last updated: 2026-01-30

Locations

1 site across 1 country: China