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

NCT06909877 | Recruiting Phase 1 DMC

• 1 other identifier: HH2853-G202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Relapsed/Refractory; Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Phase Ib: To determine the RP2D of HH2853 in PTCL patients

  Determine RP2D of HH2853

  28-day treatment cycles

• Phase II: 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

  ORR will be based on the blinded independent review committee (BIRC). Assessment of oncologic response will be performed according to the 2014 edition of the Lugano Criteria for Efficacy \[Lugano\]

  28-day treatment cycles

Secondary Outcomes (25)

• Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

  28-day treatment cycles

• Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

  28-day treatment cycles

• Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

  28-day treatment cycles

• Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

  28-day treatment cycles

• Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853

  28-day treatment cycles

Other Outcomes (2)

• Phase Ib and II: 1. To explore biomarkers related to response and effect of HH2853

  28-day treatment cycles

• Phase Ib and II: 2. To explore the correlation between HH2853 exposure with safety, efficacy and pharmacokinetic parameters

  28-day treatment cycles

Study Arms (1)

Dose escalation and expansion study of HH2853

EXPERIMENTAL

To determine the RP2D of HH2853 in PTCL patients.

Drug: HH2853 Tablets

Interventions

HH2853 Tablets DRUG

25mg, 100mg and 200 mg BID oral administration

Also known as: HH2853

Dose escalation and expansion study of HH2853

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.
• The Eastern cooperative oncology group (ECOG) score 0-1.
• Life expectancy ≥ 3 months before starting HH2853 treatment.
• Sufficient bone marrow, liver and renal functions.

You may not qualify if:

• main criteria:
• Previous treatment with EZH2 or EZH1/2 inhibitors.
• Central nervous system invasion.
• Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).
• Received medications that are known potent CYP3A4 inducers/inhibitors within 1 week prior to first dose.

Sponsors & Collaborators

• Haihe Biopharma Co., Ltd.: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Chengdu, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Tongyu Li, MD

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiying Jia

CONTACT

86-20568888; haiying.jia@haihepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: July 27, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): July 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)