SIM1811-03 for Cutaneous T-Cell Lymphoma

Not currently recruiting at 5 trial locations

Overseen By Bijoyesh Mookerjee, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Must not be taking: Corticosteroids, Cytotoxic chemotherapy

Disqualifiers: Autoimmune disease, CNS metastases, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SIM1811-03, designed to combat certain advanced cancers and a type of skin lymphoma known as cutaneous T-cell lymphoma (CTCL). The main goal is to assess the safety and effectiveness of SIM1811-03 for individuals whose cancer has returned or not responded to standard treatments. It offers a promising option for those with advanced solid tumors or CTCL who have tried at least two other treatments without success and have measurable lesions. Participants must have stable organ function and not have certain health conditions, such as active infections or autoimmune diseases. As a Phase 1 trial, this research focuses on understanding how SIM1811-03 works in people, offering participants the chance to be among the first to receive this new treatment.

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

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you should not have used certain cancer treatments or corticosteroids recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SIM1811-03 is likely to be safe for humans?

Research shows that SIM1811-03 is undergoing its first human trials to assess safety. Earlier studies involved adults with advanced solid tumors and a type of skin lymphoma. As a Phase 1 trial, the primary goal is to determine the treatment's safety and how the body processes it.

SIM1811-03 is a new monoclonal antibody that targets a specific part of the immune system. Detailed information on side effects or tolerance remains limited, as studies are still in early stages. However, Phase 1 trials prioritize safety, with close monitoring for any negative effects.

In summary, while detailed data is limited, current research is carefully observing responses to SIM1811-03 to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Cutaneous T-Cell Lymphoma, which often involve systemic therapies like chemotherapy or targeted drugs, SIM1811-03 is unique because it is a monotherapy that might target the disease more directly. Researchers are excited about SIM1811-03 because it could offer a new mechanism of action that specifically addresses the cancerous T-cells, potentially leading to fewer side effects and improved efficacy. This approach could provide an alternative for patients who have limited options and improve their quality of life.

What evidence suggests that SIM1811-03 might be an effective treatment for cutaneous T-cell lymphoma?

Research has shown that SIM1811-03, administered as monotherapy in this trial, could be a promising treatment for certain cancers. Lab studies have demonstrated its effectiveness in killing cancer cells with a protein called TNFR2, often present in some tumors. SIM1811-03 is a monoclonal antibody, designed to target and block specific proteins like TNFR2. Although human studies have provided limited information, early lab results are encouraging and suggest that SIM1811-03 might help manage cutaneous T-cell lymphoma. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors or cutaneous T-cell lymphoma (CTCL) who have failed at least two systemic therapies. Participants must have measurable lesions, a life expectancy of more than 12 weeks, and be able to provide tissue samples. They should not have other recent malignancies, autoimmune diseases, organ transplants, or untreated central nervous system metastases.

Inclusion Criteria

Written informed consent must be obtained prior to any procedures that are not considered standard of care

I can provide samples of my tumor for the study.

I have CTCL (either Mycosis fungoides or Sézary Syndrome) and at least 2 treatments haven't worked for me.

Exclusion Criteria

I haven't been in a drug trial or used experimental devices in the last 28 days.

Other conditions that researchers consider inappropriate for inclusion

History of immunodeficiency (including HIV infection)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Phase Ia

Dose escalation to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SIM1811-03

28 days per cycle

Visits on Days 1, 2, 4, 8, and 15 of each cycle

Treatment Phase Ib

Dose expansion at RD level to assess anti-tumor activity of SIM1811-03

28 days per cycle

Visits on Days 1, 2, 4, 8, and 15 of each cycle

Safety Follow-up

Monitoring for adverse events and safety assessments

90 days after last dose

Progression-Free Survival (PFS) Follow-up

Continued tumor assessments until disease progression, initiation of subsequent therapies, or death

Up to 1 year

Survival Follow-up

Participants are followed for overall survival

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• SIM1811-03

Trial Overview

The trial is testing SIM1811-03, an experimental antibody targeting the TNFR2 receptor in patients with certain types of cancer. It's a first-in-human study where doses are increased gradually to find safe levels before expanding to more participants.

How Is the Trial Designed?

Group I: SIM1811-03 Monotherapy Experimental Treatment 1 Intervention

All participants receive SIM1811-03 alone

Who Is Running the Clinical Trial?

Jiangsu Simcere Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

75

Recruited

15,700+

Ren Jinsheng

Jiangsu Simcere Pharmaceutical Co., Ltd.

Chief Executive Officer since 2004

Bachelor's degree from Shanxi College of Finance and Economics, EMBA from China Europe International Business School

Tang Renhong

Jiangsu Simcere Pharmaceutical Co., Ltd.

Chief Medical Officer since 2022

MD

Published Research Related to This Trial

In a study of 118 patients with cutaneous T-cell lymphomas (CTCL), including mycosis fungoides (MF) and Sézary syndrome (SS), the overall survival for MF patients was 17.7 years, while SS patients had a median survival of 3.5 years, indicating significant differences in outcomes based on the type of CTCL.

The most common treatments for MF included low-dose methotrexate and interferon-alpha, while SS patients often received bexarotene and extracorporeal photopheresis, highlighting the need for more innovative therapies to be integrated into earlier treatment lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of 118 Patients With Cutaneous T-Cell Lymphomas: A Single-Center Experience. Polgárová, K., Polívka, J., Kodet, O., et al.[2022]

Cutaneous T-cell lymphomas (CTCLs), particularly mycosis fungoides with large cell transformation, have a low 5-year overall survival rate of 32% for skin involvement and only 7% for cases with extracutaneous spread.

Histone deacetylase inhibitors are promising new targeted treatments for T-cell lymphomas, showing significant activity in combating these difficult-to-treat cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histone Deacetylase Inhibitors for Cutaneous T-Cell Lymphoma. Duvic, M.[2018]

Total skin electron irradiation (TSEI) was effective in treating cutaneous T-cell lymphoma (CTCL) in 14 Indian patients, with 10 achieving complete remission after treatment.

Despite the initial success of TSEI, the long-term prognosis remains poor, as only 5 patients were disease-free after 5 years, highlighting the need for ongoing monitoring and potential additional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous T-cell lymphoma treated with electron beam irradiation in Indian patients. Parida, DK., Verma, KK., Chander, S., et al.[2019]

Cutaneous T-cell lymphomas (CTCL) have high relapse rates, but survival is generally not significantly affected in low-stage disease, while aggressive subtypes show reduced survival rates.

Recent research has identified new treatment strategies targeting tumor-infiltrating immune cells and the tumor microenvironment, focusing on restoring immunosurveillance and utilizing novel approaches like NF-κB or JAK inhibition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Treatment Concepts for Cutaneous T-Cell Lymphoma Based on Microenvironment Modulation. Leuchte, K., Schlaak, M., Stadler, R., et al.[2018]

Cutaneous T-cell lymphomas, including mycosis fungoides and Sezary syndrome, have distinct clinical behaviors, with mycosis fungoides being more indolent and Sezary syndrome being more aggressive, highlighting the need for tailored treatment approaches.

Current treatments include a variety of skin-directed and systemic therapies, but over 20% of patients with early-stage disease experience progression, indicating a significant need for more effective and durable treatment options, especially for advanced stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of currently available therapies for the mycosis fungoides and Sezary syndrome variants of cutaneous T-cell lymphoma. Whittaker, SJ., Foss, FM.[2007]

Citations

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SIM1811-03 in participants with advanced solid tumor and ...

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SIM0235 was shown to have a significant killing effect on TNFR2-positive cells in ADCC and ADCP in vitro studies. Several in vivo models have ...

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An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors.

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696P SIM1811-03 (SIM0235), an anti-tumor necrosis factor ...

SIM1811-03 is a humanized IgG1 monoclonal antibody that targets TNFR2,which demonstrated antitumor active in non-clinical models as single agent.

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This is a first in human, open-label, dose escalation and expansion Phase I study of SIM1811-03 in adult patients with advanced tumors.

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Cutaneous T-Cell Lymphoma (CTCL) (DBCOND0071861)

A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma. SIM1811-03. treatment, 1, unknown_status. NCT03380026.