Galinpepimut-S for Acute Myeloid Leukemia

(REGAL Trial)

Not currently recruiting at 87 trial locations

Overseen By Clinical Trials Info at Sellas

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sellas Life Sciences Group

Must not be taking: Anti-AML therapy, Live vaccines

Disqualifiers: CNS leukemia, Active infection, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 12

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment, galinpepimut-S, for individuals with acute myeloid leukemia (AML) in their second or later complete remission. The trial compares galinpepimut-S to the best available therapy chosen by doctors to determine which option extends patient survival. Those diagnosed with AML in their second complete remission, who are ineligible for a stem cell transplant, may be suitable for this study. As a Phase 3 trial, this study serves as the final step before potential FDA approval, offering participants the opportunity to contribute to a promising treatment's journey toward widespread availability.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot continue any anti-AML therapy or certain other treatments like systemic corticosteroids above a specific dose. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that galinpepimut-S, a vaccine designed to strengthen the immune system, was safe in earlier studies. It is usually well-tolerated by people with acute myeloid leukemia (AML). In these studies, patients did not experience serious side effects, and the treatment was considered safe. Most patients handled the treatment without major issues. This information should reassure anyone considering joining a trial with galinpepimut-S. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for AML?

Unlike the standard treatments for acute myeloid leukemia, which often involve chemotherapy or medications like HMAs, venetoclax, or low-dose cytarabine, Galinpepimut-S uses a different approach. This treatment is unique because it leverages the body's immune system to fight cancer by targeting a specific protein found on leukemia cells. Researchers are excited about Galinpepimut-S because it aims to boost the immune response in a phased manner, potentially leading to longer-lasting remission with fewer side effects compared to traditional therapies. The use of an immune system booster like GM-CSF, along with the Montanide adjuvant, is designed to enhance the effectiveness of the treatment further, offering new hope for patients with this challenging disease.

What evidence suggests that galinpepimut-S might be an effective treatment for acute myeloid leukemia?

Research shows that Galinpepimut-S (GPS), which participants in this trial may receive, may help treat acute myeloid leukemia (AML). In an earlier study, 80% of patients exhibited a strong immune response, indicating that the body is effectively fighting the cancer. GPS functions like a vaccine by targeting the WT1 protein, often found in high amounts in AML cells. Using GPS as ongoing treatment has shown promising results, particularly for patients in their second or later remission. These findings suggest that GPS could help patients maintain remission longer. ^{1 2 3 6 7}

Who Is on the Research Team?

Dragan Cicic Chief Development Officer, MD

Principal Investigator

Sellas Life Sciences Group

Are You a Good Fit for This Trial?

Adults over 18 with acute myeloid leukemia (AML) in second remission, not eligible for stem cell transplant, and who have good liver function. Women must be non-pregnant, postmenopausal or surgically sterile; sexually active participants must use contraception. Excludes those with severe allergies to certain immune stimulants, other cancers within 5 years, autoimmune diseases requiring treatment in the past 2 years, CNS leukemia or recent investigational drug use.

Inclusion Criteria

I received my last leukemia treatment at least 4 weeks ago.

My liver is functioning well.

I agreed to join within 6 months after my cancer went into remission for the second time.

Exclusion Criteria

I have received a transplant from another person.

My leukemia has spread to my brain or spinal cord.

I have been treated for an autoimmune disease in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive galinpepimut-S injections in three phases: initial immunization induction, early immune booster, and late immune booster

52 weeks

Bi-weekly to every 6 weeks (in-person)

End of Treatment

An End of Treatment visit is conducted 30 days following the last dose of GPS

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of leukemia and overall survival

Up to 156 weeks

Every 4 weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Best Available Therapy
• Galinpepimut-S

Trial Overview The trial is testing Galinpepimut-S (GPS), a new therapy against the best available treatments chosen by investigators for AML patients in their second complete remission. The main goal is to compare overall survival rates between GPS and existing therapies.

How Is the Trial Designed?

Group I: Galinpepimut-S + Montanide + GM-CSF Experimental Treatment 3 Interventions

Galinpepimut-S injections will be administered as follows, until disease relapse: 1. First 6 galinpepimut-S injections: every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. The first series of 6 injections of galinpepimut-S define the initial immunization induction phase. 2. Injections 7 to 12: every 4 weeks (Weeks 14 - 34) followed by a 6-week period of no treatment. The second series of injections of galinpepimut-S define the early immune booster phase. 3. Injections 13 to 15: every 6 weeks (Weeks 40 - 52). The third series of injections of galinpepimut-S define the late immune booster phase. 4. Injections 16-20: every 2 months (in Year 2). 5. Injection 21 and thereafter: every 3 months (in Year 3). Y2 and Y3 define the maintenance phase. Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered two days before and on the same day as the galinpepimut-S + Montanide injection.

Group II: Best Available Therapy Active Control 5 Interventions

Four options, as monotherapy or as combination of agents listed below, (per treating investigator's choice): 1. Observation (whereby palliative management with hydroxyurea is allowed), or 2. HMA (decitabine or azacitidine), and/or 3. Venetoclax, and/or 4. Low-dose ara-C

Who Is Running the Clinical Trial?

Sellas Life Sciences Group

Lead Sponsor

Trials

9

Recruited

770+

PPD Development, LP

Industry Sponsor

Published Research Related to This Trial

Acute myeloid leukemia (AML) treatment has seen little change in 40 years, but new agents like IDH inhibitors and antibody-drug conjugates show promise in improving outcomes, either alone or with traditional chemotherapy.

A variety of novel therapies, including cytotoxic agents, epigenetic modifiers, and targeted inhibitors, are currently being tested in clinical trials, indicating a potential shift in AML management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapies for acute myeloid leukemia. Saygin, C., Carraway, HE.[2023]

Current chemotherapy for acute myeloid leukemia (AML) may have reached its limits, prompting a shift towards more targeted therapies that consider the disease's molecular and biological characteristics.

Targeting the CD33 antigen with antibody-directed treatments has shown promise, especially in relapsed cases, but is unlikely to replace conventional chemotherapy; ongoing trials are exploring the effectiveness of combining these targeted therapies with traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting treatment in AML. Burnett, AK., Knapper, S.[2016]

In 2017, the FDA approved five new drugs for treating acute myeloid leukemia (AML), including targeted therapies for specific genetic mutations (FLT3 and IDH2) and a new formulation of cytarabine-daunorubicin for certain types of AML.

The combination of the BCL-2 inhibitor venetoclax with low-intensity therapy showed promising results for older patients who are not suitable for intensive chemotherapy, indicating a shift towards more tailored treatment options in AML.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midostaurin, enasidenib, CPX-351, gemtuzumab ozogamicin, and venetoclax bring new hope to AML. Wei, AH., Tiong, IS.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39606837/

REGAL: galinpepimut-S vs. best available therapy as ... Patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) have very poor long-term outcomes. Allogeneic stem cell transplantation (allo-SCT) ...

2. ir.sellaslifesciences.com ir.sellaslifesciences.com/news/News-Details/2025/SELLAS-Life-Sciences-Announces-Positive-Outcome-of-Interim-Analysis-for-its-Pivotal-Phase-3-REGAL-Trial-of-GPS-in-Acute-Myeloid-Leukemia/default.aspx

News Details 80% of randomly selected REGAL GPS patients showed a specific T-cell immune response, surpassing the results from the previous Phase 2 study.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04229979

Study Details | NCT04229979 | Galinpepimut-S Versus ... This is an open-label, multicenter, randomized, parallel groups study of galinpepimut-S (GPS) vs. best available treatment (BAT) in patients with AML in second ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS7074

A randomized, open-label study of the efficacy and safety ... Maintenance therapy with Galinpepimut-S (GPS), a multivalent heteroclitic WT1 peptide vaccine, has shown promising activity in patients with AML ...

5. onclive.com onclive.com/view/maintenance-galinpepimut-s-appears-effective-and-safe-in-aml-in-second-cr

Maintenance Galinpepimut-S Appears Effective and Safe ... Galinpepimut-S (GPS) demonstrated early efficacy signals in patients with acute myeloid leukemia (AML) in second complete remission (CR2) or later.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34053383/

Galinpepimut-S (GPS): an investigational agent for the ... We summarize and examine the structure, key features, safety, and efficacy data of galinpepimut-S (GPS) for AML. GPS has been shown to be safe and tolerable.

7. ashpublications.org ashpublications.org/bloodadvances/article/2/3/224/15779/Phase-2-trial-of-a-multivalent-WT1-peptide-vaccine

Phase 2 trial of a multivalent WT1 peptide vaccine ... A heteroclitic WT1 peptide vaccine is well tolerated and induces immunologic responses in most acute myeloid leukemia patients post-CR1.