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RecruitingNCT06909877Updated Jan 30, 2026

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

A Phase 1/2 interventional study of HH2853 Tablets in Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL), sponsored by Haihe Biopharma Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Haihe Biopharma Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

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

Keywords

  • Relapsed/Refractory
  • Peripheral T-cell Lymphoma
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Dose escalation and expansion study of HH2853

    To determine the RP2D of HH2853 in PTCL patients.

    Drug: HH2853 Tablets

Interventions

  • DrugHH2853 Tablets

    25mg, 100mg and 200 mg BID oral administration

    Also known as: HH2853

05

What researchers measure

Primary outcomes

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

    Determine RP2D of HH2853

    Time frame: 28-day treatment cycles

  2. 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 \[Lugano\]

    Time frame: 28-day treatment cycles

Secondary outcomes

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

    Investigator assessed: complete response rate (CRR)

    Time frame: 28-day treatment cycles

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

    Duration of response (DoR)

    Time frame: 28-day treatment cycles

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

    Disease control rate (DCR)

    Time frame: 28-day treatment cycles

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

    Time to response (TTR)

    Time frame: 28-day treatment cycles

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

    Area under the concentration-time curve (AUC)

    Time frame: 28-day treatment cycles

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

    Maximum plasma concentration (Cmax)

    Time frame: 28-day treatment cycles

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

    Trough concentration (Cmin)

    Time frame: 28-day treatment cycles

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

    Time to maximum plasma concentration (Tmax)

    Time frame: 28-day treatment cycles

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

    Apparent clearance (CL/F)

    Time frame: 28-day treatment cycles

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

    Terminal half-life (t1/2)

    Time frame: 28-day treatment cycles

  11. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    ORR assessed by investigator

    Time frame: 28-day treatment cycles

  12. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    Complete response rate (CRR)

    Time frame: 28-day treatment cycles

  13. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    Progression-free survival (PFS)

    Time frame: 28-day treatment cycles

  14. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    Duration of response (DoR)

    Time frame: 28-day treatment cycles

  15. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    Disease control rate (DCR)

    Time frame: 28-day treatment cycles

  16. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    Time to response (TTR)

    Time frame: 28-day treatment cycles

  17. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    Overall survival (OS) by BIRC

    Time frame: 28-day treatment cycles

  18. Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy

    Overall survival (OS) by investigator

    Time frame: 28-day treatment cycles

  19. Phase II: 2. To evaluate the safety and tolerability of HH2853

    Duration and severity of adverse events (AEs)

    Time frame: 28-day treatment cycles

  20. Phase II: 3. To characterize the population pharmacokinetic profile of HH2853

    Area under the concentration-time curve (AUC)

    Time frame: 28-day treatment cycles

  21. Phase II: 3. To characterize the population pharmacokinetic profile of HH2853

    Maximum plasma concentration (Cmax)

    Time frame: 28-day treatment cycles

  22. Phase II: 3. To characterize the population pharmacokinetic profile of HH2853

    Steady-state trough concentration (Cmin)

    Time frame: 28-day treatment cycles

  23. Phase II: 3. To characterize the population pharmacokinetic profile of HH2853

    Time to maximum plasma concentration (Tmax)

    Time frame: 28-day treatment cycles

  24. Phase II: 3. To characterize the population pharmacokinetic profile of HH2853

    Apparent clearance (CL/F)

    Time frame: 28-day treatment cycles

  25. Phase II: 3. To characterize the population pharmacokinetic profile of HH2853

    Half life (t1/2)

    Time frame: 28-day treatment cycles

Other outcomes

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

    mutation status of EZH2

    Time frame: 28-day treatment cycles

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

    Correlation between exposure (Cmax or AUC) and safety/efficacy/pharmacodynamic biomarkers (trimethylation of histone H3 at lysine 27 \[H3K27me3\])

    Time frame: 28-day treatment cycles

06

Study locations

1 of 1 sites recruiting
  • Sichuan Cancer Hospital
    Chengdu, Chengdu, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD based on business strategy.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06909877
Lead sponsor
Haihe Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
Jul 27, 2022
Primary completion
Oct 31, 2025
Completion
Jul 30, 2027 (estimated)
Last update
Jan 30, 2026

Study contacts

Haiying Jia
Contact
haiying.jia@haihepharma.com
86-20568888
Tongyu Li, MD
principal investigator · Sichuan Cancer Hospital and Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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