Galinpepimut-S for Acute Myeloid Leukemia

(REGAL Trial)

Recruiting at 75 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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called GPS, which helps the immune system fight cancer, in patients with AML who have experienced multiple remissions. The goal is to see if GPS can improve survival rates by making the body's natural defenses better at destroying cancer cells.

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.

What data supports the effectiveness of the treatment Galinpepimut-S for Acute Myeloid Leukemia?

The research highlights the potential of targeted therapies and novel agents in improving outcomes for acute myeloid leukemia (AML), especially in older patients. While Galinpepimut-S is not specifically mentioned, the focus on targeted approaches and immunotherapies suggests a promising direction for treatments like Galinpepimut-S that may leverage similar mechanisms. ^{1 2 3 4 5}

What makes the drug Galinpepimut-S unique for treating acute myeloid leukemia?

Galinpepimut-S is a novel treatment for acute myeloid leukemia that differs from traditional chemotherapy by potentially targeting specific proteins or pathways involved in the disease, offering a more personalized approach. This is in contrast to the standard '7 + 3' chemotherapy regimen, which has remained largely unchanged for decades. ^{6 7 8 9 10}

Research Team

Dragan Cicic Chief Development Officer, MD

Principal Investigator

Sellas Life Sciences Group

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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 (between Weeks 14 and 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 and thereafter: every 6 weeks from Weeks 40 and thereafter. The third series of injections of galinpepimut-S define the late immune booster phase. Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered one day 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+

Findings from Research

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Flexible low-intensity combination chemotherapy for elderly patients with acute myeloid leukaemia: a multicentre, phase II study. [2018]

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

Targeting treatment in AML. [2016]

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

Upfront therapy of acute myeloid leukemia. [2021]

4. France pubmed.ncbi.nlm.nih.gov

[Management of AML in the elderly]. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Which novel agents hold the greatest promise in AML? [2020]

6. England pubmed.ncbi.nlm.nih.gov

A review of FDA-approved acute myeloid leukemia therapies beyond '7 + 3'. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Novel and emerging drugs for acute myeloid leukemia: pharmacology and therapeutic activity. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Emerging therapies for acute myeloid leukemia. [2023]

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

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

AC220 and AraC cause differential inhibitory dynamics in patient-derived M5-AML with FLT3-ITD and, thus, ultimately distinct therapeutic outcomes. [2017]