ONO-4685 for Lymphoma

Recruiting at 14 trial locations

Overseen By Ono Pharma USA, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ono Pharmaceutical Co. Ltd

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: CNS involvement, ATLL, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

217 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a new drug called ONO-4685 in patients whose T cell Lymphoma has come back or did not respond to previous treatments. Researchers aim to see if the drug is safe, how it moves through the body, and if it helps reduce the cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug ONO-4685 different from other lymphoma treatments?

The research provided does not contain specific information about ONO-4685, so its unique features compared to existing lymphoma treatments are not detailed. ^{1 2 3 4 5}

Research Team

Project Leader

Principal Investigator

Ono Pharma USA Inc

Eligibility Criteria

Adults over 18 with relapsed or refractory T cell lymphoma, who've had at least two prior treatments and have measurable disease, can join this trial. They must not be pregnant, have a central nervous system involvement, HIV, hepatitis B or C infections, recent tuberculosis infection, severe allergies to monoclonal antibodies or corticosteroids.

Inclusion Criteria

Life expectancy of at least 3 months

I have PTCL with at least one tumor that can be measured.

My diagnosis is a specific type of T-cell lymphoma.

Exclusion Criteria

I do not have an active infection like HIV or hepatitis B/C.

I have a cancer type other than T-cell lymphoma.

I still have side effects from previous cancer treatments that haven't improved.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ONO-4685 monotherapy to assess safety, tolerability, and preliminary efficacy

3 weeks

Weekly visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Regular visits for pharmacokinetics and immunogenicity assessments

Long-term follow-up

Participants are monitored for long-term safety and antitumor activity

Up to 1 year

Treatment Details

Interventions

• ONO-4685

Trial Overview The trial is testing ONO-4685's safety and effectiveness for patients with specific types of T cell lymphoma that haven't responded well to previous treatments. It will look at how the body processes the drug and its preliminary success in treating the cancer.

Participant Groups

Group I: ONO-4685 monotherapy Experimental Treatment 1 Intervention

Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

Who Is Running the Clinical Trial?

Ono Pharmaceutical Co. Ltd

Lead Sponsor

Trials

182

Recruited

97,100+

Shinji Takai

Ono Pharmaceutical Co. Ltd

Chief Medical Officer since 2023

MD from an unspecified institution

Gyo Sagara

Ono Pharmaceutical Co. Ltd

Chief Executive Officer since 2024

PhD in Pharmaceutical Sciences from Kyoto University

Findings from Research

Complete remission rates for adult patients with high-grade non-Hodgkin's lymphoma range from 50% to 80%, with average disease-free survival rates of 40-50% at 3 years and 30-35% at 5 years, indicating a significant potential for successful treatment.

CHOP chemotherapy remains the standard treatment, but aggressive regimens and dose intensification have not shown improved overall survival, suggesting that supportive therapies like cytokines may be necessary to maintain full-dose treatment schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapy of high-grade non-Hodgkin's lymphoma]. Jäger, U., Karth, GD., Knapp, S., et al.[2015]

Combination chemotherapy with CHOP (cyclophosphamide, hydroxydaunorubin, vincristine, and prednisone) is the first-line treatment for high-grade non-Hodgkin's lymphomas, achieving long-term remission or potential cure in 30-50% of advanced cases.

For low-grade lymphomas, a watch-and-wait approach is often used until treatment is necessary, with moderate-intensity chemotherapy options available, and new therapies like maintenance with interferon-alpha and innovative agents like purine analogues showing promise for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Hodgkin's lymphomas--current status of therapy and future perspectives. Hiddemann, W.[2019]

In a study involving 40 dogs with peripheral nodal lymphoma, those treated with the full L-CHOP chemotherapy protocol (including prednisone) had a median progression-free survival time of 292 days, compared to 142.5 days for those who received the L-CHO protocol without prednisone.

The trial found that omitting prednisone did not improve progression-free survival, and while serious adverse events were more common in the L-CHO group, the difference was not statistically significant, suggesting that the study may not have been large enough to detect meaningful differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effect of prednisone omission from a multidrug chemotherapy protocol on treatment outcome in dogs with peripheral nodal lymphomas. Childress, MO., Ramos-Vara, JA., Ruple, A.[2017]

Paclitaxel and docetaxel, both derived from the yew tree, have shown significant antitumor activity in non-Hodgkin's lymphoma, with response rates of 30% CR and 14% PR for paclitaxel, and up to 29.4% response rate for docetaxel in various studies involving relapsed lymphomas.

Rituximab, a monoclonal antibody targeting CD20, demonstrated a 46% response rate in patients with relapsed low-grade lymphoma, and when combined with CHOP chemotherapy, it resulted in complete or partial responses in all newly diagnosed patients, indicating its potential effectiveness in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New antitumor drugs for non-Hodgkin's lymphoma]. Ohnishi, K., Ohno, R.[2018]

In a study of 49 dogs with intermediate- and high-grade peripheral nodal T-cell lymphoma, L-CHOP chemotherapy resulted in a high overall response rate of 98%, indicating that this treatment is effective for this type of cancer.

However, the median progression-free survival (PFS) was relatively short, with 103 days for the placebo group compared to 64 days for the group receiving the monoclonal antibody AT-005, suggesting that while the treatment is effective, it may not significantly prolong survival time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial evaluating chemotherapy alone or chemotherapy and a novel monoclonal antibody for canine T-cell lymphoma: A multicentre US study. Musser, ML., Clifford, CA., Bergman, PJ., et al.[2022]

References

1. Austria pubmed.ncbi.nlm.nih.gov

[Therapy of high-grade non-Hodgkin's lymphoma]. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Non-Hodgkin's lymphomas--current status of therapy and future perspectives. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effect of prednisone omission from a multidrug chemotherapy protocol on treatment outcome in dogs with peripheral nodal lymphomas. [2017]

4. Japan pubmed.ncbi.nlm.nih.gov

[New antitumor drugs for non-Hodgkin's lymphoma]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Randomised trial evaluating chemotherapy alone or chemotherapy and a novel monoclonal antibody for canine T-cell lymphoma: A multicentre US study. [2022]