HH2853 for Non-Hodgkin's Lymphoma

Recruiting at 17 trial locations

Overseen By Haiyue Chen

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Haihe Biopharma Co., Ltd.

Must not be taking: Anticancer, Antiplatelet, Antithrombotic, others

Disqualifiers: CNS metastases, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

254 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called HH2853 for certain types of non-Hodgkin's lymphoma and some advanced solid tumors. Researchers aim to determine the right dosage and assess the treatment's effectiveness in controlling or shrinking these cancers. The trial targets individuals with specific types of non-Hodgkin's lymphoma, such as follicular lymphoma or diffuse large B-cell lymphoma, who have not had success with other treatments. Participants should have these cancer types and have undergone previous unsuccessful treatments. This trial could be an option for those with limited or no other treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, it mentions that any cancer-directed therapy should be stopped at least 28 days before the first dose, and certain medications are prohibited within 2 weeks of starting the trial.

Is there any evidence suggesting that HH2853 is likely to be safe for humans?

Research shows that HH2853, a new treatment being tested for non-Hodgkin's lymphoma, is generally safe. Studies have found that taking 400 mg of HH2853 twice a day is usually well-tolerated by patients. Some participants might experience side effects, but these studies suggest that the treatment does not cause serious harm to most. This indicates it is safe enough for continued testing in clinical trials, and ongoing studies will provide more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Non-Hodgkin's Lymphoma, which often include chemotherapy, radiation, or immunotherapy, HH2853 offers a novel approach through its unique administration and formulation. HH2853 is administered orally on a twice-daily schedule in 28-day cycles, which could potentially offer more consistent drug exposure and easier management for patients. Additionally, it's not adjusted based on weight or body surface area, simplifying the dosing process. Researchers are excited about its potential to improve treatment effectiveness and patient quality of life by offering a more targeted and convenient option.

What evidence suggests that HH2853 might be an effective treatment for Non-Hodgkin's Lymphoma?

Research has shown that HH2853, the treatment under study in this trial, yields promising results for non-Hodgkin's lymphoma (NHL). In studies involving 57 patients, about 28% responded positively, with some achieving complete remission. HH2853 blocks certain proteins that aid cancer cell growth. This treatment has demonstrated strong anti-tumor effects and is generally safe. Early results from various trials suggest HH2853 could become an important option for patients with difficult-to-treat cancers like NHL. ^{1 2 3 4 6}

Who Is on the Research Team?

Fugen Li

Principal Investigator

Haihe Biopharma Co., Ltd.

Are You a Good Fit for This Trial?

Adults with certain types of non-Hodgkin's lymphoma or advanced solid tumors who have relapsed or are not responding to treatment. Participants must be in good physical condition (ECOG ≤1), able to provide consent, and have a life expectancy over 3 months. They should not have had recent cancer treatments, major surgeries, or active infections and must meet specific lab values.

Inclusion Criteria

I have non-Hodgkin's lymphoma that has returned or didn't respond to treatment, and I've had 2-5 prior treatments.

My PTCL has returned or didn't respond after 1 to 4 treatments.

Provided signed written informed consent prior to initiation of any study-related procedures

Exclusion Criteria

I haven't had any cancer treatments recently.

I have not had major surgery recently.

My brain metastases are causing symptoms and need more medication to manage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Dose Escalation

Accelerated titration with Bayesian Optimal Interval design to assess DLT, safety, tolerability, and establish MTD/RP2D

28-day treatment cycles

Continuous monitoring during treatment cycles

Phase I Dose Extension

Further evaluation of tolerability, pharmacokinetics, and efficacy at safe doses

28-day treatment cycles

Continuous monitoring during treatment cycles

Phase II

Evaluation of clinical activity in specific patient cohorts with relapsed/refractory conditions or genetic alterations

28-day treatment cycles

Continuous monitoring during treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HH2853

Trial Overview HH2853 Tablets are being tested for safety and effectiveness against various cancers. This trial has three parts: an initial phase to find the right dose, an extension of that phase, and a second phase for further evaluation. The drug is taken orally twice daily in continuous 28-day cycles.

How Is the Trial Designed?

Group I: HH2853 administered on a BID schedule in continuous 28-day treatment cycles Experimental Treatment 1 Intervention

HH2853 is supplied as tables with dosage strength of 25mg and 200mg. HH2853 Tablet will be administered orally on a continuous twice daily (BID) schedule, on a flat scale of mg and not individually adjusted by weight or body surface area. A treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations. All patients will be treated with HH2853 orally on a continuous BID schedule, beginning on Cycle 1 Day 1. But patients in accelerated titration (ATD) part should be administered a single dose on the first day in order to evaluate the PK of a single dose administration. Dosing is twice daily from the second day thereafter.

Who Is Running the Clinical Trial?

Haihe Biopharma Co., Ltd.

Lead Sponsor

Trials

17

Recruited

1,900+

Published Research Related to This Trial

Localized non-Hodgkin's lymphomas, even of aggressive types, are often more widespread than initially thought, necessitating systemic chemotherapy with doxorubicin to achieve high cure rates of about 95% for stage I and 75% for stage II patients.

Despite these high cure rates, up to 30% of patients still do not respond to treatment, highlighting the need for ongoing research to better understand the biology of non-Hodgkin's lymphomas and identify patients at risk of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with localized non-Hodgkin's lymphomas provide opportunities for future research. Miller, TP., Grogan, TM.[2015]

Hodgkin's lymphoma (HL) has become one of the most curable cancers in adults, with about 80% of patients achieving long-term disease-free survival due to substantial clinical advancements.

Current treatment strategies focus on enhancing chemotherapy and radiotherapy effectiveness while reducing side effects, with ongoing trials exploring lower doses and smaller radiation fields, as well as more intense drug combinations for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line treatment of Hodgkin's lymphoma. Klimm, B., Engert, A., Diehl, V.[2007]

Hodgkin lymphoma (HL) generally has a good prognosis with standard chemotherapy and radiation, but patients with relapsed or refractory disease face poorer outcomes, highlighting the need for new treatment options.

Novel therapies, including antibody-drug conjugates targeting CD30 and immune checkpoint inhibitors, are showing promise in treating HL, and ongoing trials are investigating their use in combination with existing chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel agents in the therapy of Hodgkin lymphoma. Ansell, S.[2018]

High-grade non-Hodgkin's lymphomas (NHL) are aggressive and often present with extranodal disease, particularly in immunocompromised patients, but they respond well to chemotherapy and radiation.

The standard treatment for high-grade NHL is the CHOP regimen (doxorubicin, cyclophosphamide, oncovin, and prednisone), and factors like age, performance status, and disease stage are important for predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High-grade non-Hodgkin lymphoma: diagnosis and therapy]. Trümper, L., Pfreundschuh, M.[2015]

In a study of 111 patients with advanced non-Hodgkin's lymphoma over 7 years, factors like a complete response to treatment, low serum LDH levels, and no liver involvement were linked to better long-term survival outcomes.

For patients who achieved a complete response, the specific subtype of lymphoma, particularly classified by the Kiel classification, was crucial in predicting longer relapse-free and overall survival, highlighting the need for tailored treatment strategies based on histology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multivariate analysis of factors affecting survival in patients with high-grade histology non-Hodgkin's lymphoma. Steward, WP., Todd, ID., Harris, M., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40821900/

Safety and efficacy of HH2853, a novel EZH1/2 dual ... No treatment-related deaths were reported. Among 57 efficacy-evaluable patients, 17 (27.9%) achieved an objective response, with four complete ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00330-X/fulltext

Safety and efficacy of HH2853, a novel EZH1/2 dual ... HH2853 showed a manageable safety profile and encouraging antitumour activity in refractory solid tumours and NHLs, with particularly promising antitumour ...

3. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/304/502754/A-Multicenter-Open-Label-Single-Arm-Phase-Ib

A Multicenter, Open-Label, Single-Arm, Phase Ib Clinical Trial ... Conclusions The selective EZH1/2 dual inhibitor HH2853 demonstrated good safety and promising efficacy in r/r PTCL patients, indicating its ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04390737

Study Details | NCT04390737 | Evaluate the Safety and ... This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase ...

5. haihepharma.com haihepharma.com/en/news/details/413

Haihe Biopharma Announces Results from the Phase Ib ... This report presented the preliminary safety and efficacy data of HH2853 in patients with relapsed and/or refractory peripheral T-cell lymphoma (R/R PTCL).

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000649712304908X

A Multicenter, Open-Label, Single-Arm, Phase Ib Clinical ... The selective EZH1/2 dual inhibitor HH2853 demonstrated good safety and promising efficacy in r/r PTCL patients, indicating its potential as a therapeutic ...