Belantamab for Lupus

No longer recruiting at 4 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must be taking: Immunosuppressants, Steroids

Disqualifiers: Severe lupus flare, Unstable SLE, Catastrophic APS, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of belantamab (also known as Belantamab Mafodotin or Blenrep), a potential treatment for autoimmune diseases such as lupus, rheumatoid arthritis, and antiphospholipid syndrome. Researchers aim to observe how the body processes the drug over time. Individuals who have tried at least two treatments without success and have stable but active disease symptoms might be suitable candidates. Participants must meet specific criteria based on their condition, including certain lab test results and disease activity levels. 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.

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 team or your doctor.

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

Research has shown that belantamab has been studied for safety in other conditions. For example, in treatments for relapsed multiple myeloma, many patients experienced eye-related side effects, with 92% reporting some level of eye issues. Severe symptoms appeared in 77% of these cases, highlighting the importance of monitoring for eye problems during treatment.

Drugs for conditions like systemic lupus erythematosus often have a good chance of advancing through clinical trial phases. This suggests that despite significant side effects, there remains potential for the treatment to be considered safe and effective with further study and improvement.

The current trial is in an early phase, focusing mainly on assessing safety and understanding how the body processes the drug. This careful approach ensures thorough documentation and management of any side effects while exploring belantamab's use for lupus. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Unlike the standard treatments for lupus, which typically involve immunosuppressive drugs like corticosteroids and antimalarials, Belantamab targets a specific protein called BCMA (B-cell maturation antigen) on the surface of B cells. This targeted approach may help reduce lupus symptoms by directly affecting the cells involved in the disease without broadly suppressing the immune system. Researchers are excited about Belantamab because its mechanism could potentially offer a more precise treatment with fewer side effects compared to the current, more generalized therapies.

What evidence suggests that belantamab might be an effective treatment for lupus?

Researchers are investigating belantamab as a potential treatment for systemic lupus erythematosus, a disease where the immune system mistakenly attacks healthy tissue. Participants in this trial will receive belantamab, which targets certain immune cells and may help with lupus. Although specific data on belantamab's effectiveness for lupus is limited, studies have shown that 73% of drugs in early testing for this condition successfully advance to the next phase. This suggests a good chance for belantamab's continued development if it initially proves safe and effective. Early results from similar treatments are promising, but more research is needed to confirm these benefits specifically for lupus. ^{1 2 3 4 6}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 75 who have moderate to severe systemic lupus erythematosus (SLE), a chronic autoimmune disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

I am using or willing to use contraception.

My lupus is moderate to severe.

Body mass index (BMI) from 18 to 32 kilograms per square meter (kg/m²) (BMI = weight/height^2), inclusive, and body weight of ≥40 kg

Exclusion Criteria

I have had a severe lupus flare-up recently that required immediate treatment.

My lupus symptoms are getting worse.

My lupus has caused permanent damage to one or more of my organs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of belantamab

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belantamab

Trial Overview The study is testing the safety of belantamab, a medication given through an IV infusion, in treating SLE. It will also monitor how the drug's levels change in the body over time and how the body responds to it.

How Is the Trial Designed?

Group I: Belantamab Experimental Treatment 1 Intervention

Belantamab is already approved in United States, European Union for the following indications:

Approved in United States as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

Approved in European Union as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Published Research Related to This Trial

In a real-world study involving 331 patients with chronic liver disease, lusutrombopag demonstrated a high effectiveness, with 94% of patients avoiding preoperative platelet transfusions before invasive procedures.

The treatment was generally safe, with serious adverse events occurring in 8.76% of patients and only 3.32% experiencing adverse drug reactions, indicating a favorable safety profile for lusutrombopag.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance. Sasaki, R., Shiino, C., Imawari, M., et al.[2021]

Eltrombopag, a thrombomimetic medication, has shown promising results in treating severe thrombocytopenia in a patient with systemic lupus who did not respond to conventional therapies.

The case highlights eltrombopag's potential for full recovery in lupus-associated thrombocytopenia, suggesting it may be a valuable treatment option for similar patients, although more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful platelet count recovery in lupus-associated thrombocytopenia with the thrombopoietin agonist eltrombopag. Scheinberg, P., Singulane, CC., Barbosa, LS., et al.[2021]

In a post-marketing surveillance study involving 1033 patients with chronic liver diseases, lusutrombopag demonstrated high effectiveness, with 94.7% of patients avoiding preoperative platelet transfusions and 82.8% meeting the criteria for a significant increase in platelet count.

The safety profile of lusutrombopag was acceptable, with serious adverse reactions occurring in a small percentage of patients, and no increased risk observed in those with more severe liver disease (Child-Pugh class C) or during retreatment cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of lusutrombopag in patients who have chronic liver disease with thrombocytopenia and undergoing invasive procedures: Real-world post-marketing surveillance in Japan. Yoshiji, H., Suzuki, J., Imasaki, M., et al.[2023]

In a study of 52 Hispanic patients with refractory systemic lupus erythematosus, the addition of anti-CD20 treatment (rituximab) to ongoing immunosuppressive therapy resulted in significant clinical improvements over 6 months, including a reduction in disease activity scores and remission in various symptoms.

Rituximab was particularly effective for patients with lupus nephritis, with 38.4% achieving complete renal response, and it also significantly increased platelet counts in those with autoimmune thrombocytopenia, demonstrating its potential as a valuable treatment option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-CD20 therapy in patients with refractory systemic lupus erythematosus: a longitudinal analysis of 52 Hispanic patients. Garcia-Carrasco, M., Mendoza-Pinto, C., Sandoval-Cruz, M., et al.[2022]

In a phase 3 study involving 66 patients with chronic liver disease and severe thrombocytopenia, lusutrombopag significantly increased platelet counts, with 43.2% of patients responding positively compared to only 4.5% in the placebo group.

Lusutrombopag not only reduced the need for platelet transfusions (72.7% of patients met criteria for avoiding transfusions) but also demonstrated a safety profile similar to placebo, with fewer bleeding events reported in the treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lusutrombopag for thrombocytopenia in Chinese patients with chronic liver disease undergoing invasive procedures. Ding, Z., Wu, H., Zeng, Y., et al.[2023]

Citations

1. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/belantamab-mafodotin-gsk-systemic-lupus-erythematosus-likelihood-of-approval/

Belantamab mafodotin by GSK for Systemic Lupus ... According to GlobalData, Phase I drugs for Systemic Lupus Erythematosus have a 73% phase transition success rate (PTSR) indication benchmark ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8246766/

Pharmacokinetics of Belimumab in Children With Systemic ... The phase 2 placebo‐controlled, double‐blind PLUTO trial characterized the pharmacokinetics of belimumab plus standard systemic lupus erythematosus (SLE) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11893888/

A real-world experience of efficacy and safety ... The best overall response (ORR) and complete response rates were 40.0 and 15.0%, respectively. ORRs were lower in patients with EMD, BCMA- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06413511

NCT06413511 | A Study to Investigate the Safety and ... The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change ...

5. ajmc.com ajmc.com/view/baseline-factors-may-predict-overall-renal-response-to-therapy-in-sle

Baseline Factors May Predict Overall, Renal Response to ... A new analysis of systemic lupus erythematosus (SLE) clinical trial data has identified several factors that may help clinicians better predict which patients ...

6. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma

FDA approves belantamab mafodotin-blmf for relapsed or ... Among those receiving belantamab mafodotin-blmf in DREAMM-7, ocular toxicity occurred in 92% of patients, including Grade 3 or 4 in 77%, with 83 ...