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

Last updated: January 28, 2026
Sponsor: Haihe Biopharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Non-hodgkin's Lymphoma

Lymphoma

Treatment

HH2853 Tablets

Clinical Study ID

NCT06909877
HH2853-G202
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • main inclusion:
  1. Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolledpatients must have histologically confirmed diagnosis NHL who have received atleast one line of prior systematic treatment (and ≤ 5 lines) and relapses orrefractory. Phase Ib dose expansion part: All enrolled patients must havehistologically 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), HepatosplenicT-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheralT-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cellsources NHL at the investigator and sponsor's discretion (except highlyinvasive). All enrolled patients had relapsed or refractory diseases afterreceiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolledpatients must have histologically confirmed diagnosis of PTCL, includingsubtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL,Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis ofR/R PTCL who have received at least one line of prior systematic combinationchemotherapy 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 diagnosisby 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

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 myelodysplasticsyndrome (MDS).

  4. Received medications that are known potent CYP3A4 inducers/inhibitors within 1week prior to first dose.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: HH2853 Tablets
Phase: 1/2
Study Start date:
July 27, 2022
Estimated Completion Date:
July 30, 2027

Study 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.

Connect with a study center

  • Sichuan Cancer Hospital

    Chengdu, Chengdu
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu 1815286, Chengdu
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.