SIM1811-03 for Cutaneous T-Cell Lymphoma

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a first in human, open-label, dose escalation and expansion Phase 1 study of SIM1811-03 in adult patients with advanced solid tumors and cutaneous T-cell lymphoma. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.

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.

What data supports the effectiveness of the drug SIM1811-03 for Cutaneous T-Cell Lymphoma?

The research highlights the effectiveness of immune response modifiers and innovative agents in treating Cutaneous T-Cell Lymphoma (CTCL), suggesting that new treatments like SIM1811-03 could be beneficial. Additionally, targeting tumor-infiltrating immune cells and modulating the tumor microenvironment are promising strategies for CTCL, which may relate to the mechanisms of SIM1811-03. ^{1 2 3 4 5}

Eligibility Criteria

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

I have active cancer spread to my brain or spinal cord.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 (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]

References

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

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

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

Cutaneous T-cell lymphoma treated with electron beam irradiation in Indian patients. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of 118 Patients With Cutaneous T-Cell Lymphomas: A Single-Center Experience. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Innovative Treatment Concepts for Cutaneous T-Cell Lymphoma Based on Microenvironment Modulation. [2018]

5. Netherlands 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. [2007]