Mogamulizumab for Cutaneous T-Cell Lymphoma

Not currently recruiting at 20 trial locations

Overseen By Kyowa Kirin, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kyowa Kirin, Inc.

Disqualifiers: Large cell transformation, Allogeneic transplant, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mogamulizumab, a monoclonal antibody, for individuals with certain types of skin lymphoma, specifically mycosis fungoides (MF) and Sézary syndrome (SS). Researchers aim to assess the safety and tolerability of this treatment when administered weekly at first, then monthly. It targets those whose condition has returned or not improved after treatments like chemotherapy or interferon. Individuals diagnosed with MF or SS, whose previous treatments have failed, might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

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.

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

Research has shown that mogamulizumab is generally safe for use. Studies have found no new safety concerns with long-term use, indicating the drug remains safe even after extended use. Additionally, allergic reactions do not increase when the drug is administered intravenously over time.

Other research indicates that the safety of mogamulizumab for treating cutaneous T-cell lymphoma (CTCL) aligns with earlier clinical trials. This suggests the treatment is well-tolerated not only in controlled settings but also in everyday use.

Some patients using mogamulizumab have experienced side effects, but these are usually manageable. Overall, the drug maintains a good balance between effectiveness and safety, making it a promising option for those with CTCL. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Mogamulizumab is unique because it specifically targets and binds to the CCR4 protein, which is often present on the surface of cancerous T-cells in cutaneous T-cell lymphoma (CTCL). This targeted action differs from the broader approaches of current treatments like chemotherapy or radiation, which affect both cancerous and healthy cells. Researchers are excited about mogamulizumab because it has the potential to offer more precise treatment with fewer side effects, improving the quality of life for patients.

What evidence suggests that mogamulizumab might be an effective treatment for cutaneous T-cell lymphoma?

Research has shown that mogamulizumab, the treatment under study in this trial, effectively treats cutaneous T-cell lymphoma (CTCL). Clinical trials have demonstrated that this treatment can shrink tumors by targeting specific cancer cells. One study found that it more than doubled the time patients lived without their disease worsening compared to another treatment. In another trial, nearly half of the patients experienced long-lasting improvements in their blood, and over a quarter saw similar results in their skin. Overall, patients treated with mogamulizumab showed signs of living longer. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with certain types of skin lymphoma (CTCL) who have tried at least one systemic therapy without success. It's not open to those who've had a specific cell transformation, previous mogamulizumab treatment, or an allogeneic transplant.

Inclusion Criteria

My cancer is at a late stage and I've had at least one treatment that didn't work.

My diagnosis of mycosis fungoides or Sézary syndrome is confirmed by tissue analysis.

Exclusion Criteria

I have been treated with mogamulizumab before.

I have had a transplant from a donor.

Current evidence of large cell transformation;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive mogamulizumab weekly during induction, then every 4 weeks for up to 2 years

Up to 104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 months

What Are the Treatments Tested in This Trial?

Interventions

• Mogamulizumab

Trial Overview The study tests the safety and effects of mogamulizumab given every four weeks after initial weekly doses in patients with relapsed/refractory mycosis fungoides (MF) and Sézary syndrome (SS), which are subtypes of CTCL.

How Is the Trial Designed?

Group I: Mogamulizumab Experimental Treatment 1 Intervention

Mogamulizumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Poteligeo for:

• Mycosis fungoides
• Sézary syndrome

Approved in United States as Poteligeo for:

• Mycosis fungoides
• Sézary syndrome

Approved in Canada as Poteligeo for:

• Mycosis fungoides
• Sézary syndrome

Approved in Japan as Poteligeo for:

• Adult T-cell leukemia-lymphoma
• Cutaneous T-cell lymphoma

Who Is Running the Clinical Trial?

Kyowa Kirin, Inc.

Lead Sponsor

Trials

49

Recruited

5,700+

Citations

1. poteligeohcp.com poteligeohcp.com/efficacy/progression-free-survival/

Efficacy Data for POTELIGEO® (mogamulizumab-kpkc) POTELIGEO more than doubled median progression-free survival vs vorinostat · ORR was based on global composite response score. · Median dose intensity was >95% ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40552425/

Evaluating mogamulizumab in the treatment of primary ... Clinical trials have shown that mogamulizumab effectively targets CCR4-positive malignant T-cells, leading to tumor regression and improved ...

3. kkna.kyowakirin.com kkna.kyowakirin.com/media-center/new-data-from-mavoric-trial-sheds-light-on-key-characteristics-of-long-term-poteligeo-mogamulizumab-kpkc-responders-with-specific-subtypes-of-cutaneous-t-cell-lymphoma/

New Data from MAVORIC Trial Sheds Light on Key ... Responses in blood and skin lasting ≥6 months were seen in 49.2% and 27.4% of mogamulizumab-treated patients, respectively, compared with 5.6% and 7.5% with ...

4. sttinfo.fi sttinfo.fi/tiedote/71546686/global-registry-data-show-meaningful-overall-survival-benefit-in-patients-with-advanced-cutaneous-t-cell-lymphoma-ctcl-treated-with-poteligeo-mogamulizumab?publisherId=58763726&lang=en

Global Registry Data Show Meaningful Overall Survival ... Patients treated with mogamulizumab showed a trend toward improved OS compared to those not receiving mogamulizumab across risk-stratified ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hon.3292

Safety and effectiveness of mogamulizumab in relapsed or ... The best overall response rate was 45.8% (PTCL, 47.6%; CTCL, 39.3%). At week 31, the survival rate was 69.0% (95% confidence interval, 59.8%– ...

6. kyowakirin.com kyowakirin.com/media_center/news_releases/2020/pdf/e20200131_01.pdf

Kyowa Kirin Announces Final Safety Data of POTELIGEO® ... MAVORIC is the first pivotal trial in cutaneous T-cell lymphoma (CTCL) to use progression free survival (PFS) as a primary endpoint.

7. poteligeohcp.com poteligeohcp.com/safety/adverse-reactions/

Safety & Adverse Reactions | POTELIGEO® (mogamulizumab ... POTELIGEO has had no cumulative safety issues associated with long-term exposure1,a. No increase in rates of infusion reaction from primary analysis ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38847317/

Safety and effectiveness of mogamulizumab in relapsed or ... The safety and effectiveness of mogamulizumab for PTCL and CTCL in the real world were comparable with the data reported in previous clinical trials.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8157723/

Safety and efficacy profile of mogamulizumab (Poteligeo) in ... Based on present evidence, we believed that mogamulizumab had clinically meaningful antitumor activity with acceptable toxicity which is a novel therapy in ...