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
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.
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.
372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 328 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →Haihe Biopharma Co., Ltd. is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
Compared within Lymphoma, T-Cell, Peripheral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
main inclusion:
Exclusion Criteria:
main criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To determine the RP2D of HH2853 in PTCL patients.
Drug: HH2853 Tablets
25mg, 100mg and 200 mg BID oral administration
Also known as: HH2853
Phase Ib: To determine the RP2D of HH2853 in PTCL patients
Determine RP2D of HH2853
Time frame: 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 \[Lugano\]
Time frame: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Investigator assessed: complete response rate (CRR)
Time frame: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Duration of response (DoR)
Time frame: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Disease control rate (DCR)
Time frame: 28-day treatment cycles
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
Time to response (TTR)
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Area under the concentration-time curve (AUC)
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Maximum plasma concentration (Cmax)
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Trough concentration (Cmin)
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Time to maximum plasma concentration (Tmax)
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Apparent clearance (CL/F)
Time frame: 28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
Terminal half-life (t1/2)
Time frame: 28-day treatment cycles
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
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
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
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
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
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
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
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
Phase II: 2. To evaluate the safety and tolerability of HH2853
Duration and severity of adverse events (AEs)
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Area under the concentration-time curve (AUC)
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Maximum plasma concentration (Cmax)
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Steady-state trough concentration (Cmin)
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Time to maximum plasma concentration (Tmax)
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Apparent clearance (CL/F)
Time frame: 28-day treatment cycles
Phase II: 3. To characterize the population pharmacokinetic profile of HH2853
Half life (t1/2)
Time frame: 28-day treatment cycles
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
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
Plan to share: No — There is no plan to share IPD based on business strategy.
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Oct 2025, 39 months.
Of 31 phase 1/2 interventional studies under Lymphoma, T-Cell, Peripheral, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 65. This study's 39 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lymphoma, T-Cell, Peripheral →