Status:
RECRUITING
Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma
Lead Sponsor:
Haihe Biopharma Co., Ltd.
Conditions:
Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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.
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 mee...
Eligibility Criteria
Inclusion
- main inclusion:
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06909877
Start Date
July 27 2022
End Date
July 30 2027
Last Update
September 15 2025
Active Locations (1)
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1
Sichuan Cancer Hospital
Chengdu, Chengdu, China