Acute Myeloid LeukemiaNCT05593185
Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With AML or MDS
A study testing Galinpepimut-S in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Sellas Life Sciences Group.
Trial summary
Single patient expanded access program to provide galinpepimut-S for eligible patients with AML or MDS who have no other treatment option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Galinpepimut-S
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosed with AML or MDS, as assessed by their Treating Physician;
- Have no appropriate, comparable, or satisfactory alternative treatment available, or such alternatives have been tried without clinical success, including clinical studies;
- Inability to participate in a GPS clinical study for the disease or conditions; and
- Have a treating physician who has appropriately evaluated the benefit/risk profile for potential GPS treatment.
- Patients must have a diagnosis of either AML or MDS.
- Male or female patients > 18 years of age on the day of signing informed consent.
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- Patients, or their legal representatives, must be able to communicate well with the Treating Physician, to understand and comply with the requirements for the provision of Expanded Access to GPS.
- Patients, or their legally acceptable representatives, must be willing and able to understand and provide signed informed consent for the EAP prior to the start of treatment that fulfills Institution Review Board (IRB) guidelines.
- Patients with AML must have had undergone SCT following morphological complete remission with or without peripheral blood (PB) counts recovery (CR/CRi). Patients with MDS are not required to have had CR prior to transplant.
- Patients with AML must have had Minimal Residual Disease (MRD) positivity per flow cytometry, RT PCR or NGS prior to SCT conditioning. Patients with MDS may have had less than CR prior to SCT. There is no requirement for specific SCT conditioning and conditioning intensity could have been myeloablative or nonmyeloablative (reduced intensity) conditioning.
- Patients must be consented within 30 -120 days after the date of SCT.
- Patients may concurrently be administered HMA +/- venetoclax and/or FLT3 ITD targeted agents at the discretion of the Treating Physician, in which case their regimen of GPS administrations will continue in parallel with the prescribed HMA +/- venetoclax and/or FLT3 ITD targeted agents regimen.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3.
- Patients must have an estimated life expectancy >6 months.
- If female, patients must be postmenopausal (at least 12 sequential months of amenorrhea) or surgically sterile. Females of childbearing potential must have a negative pregnancy test.
- Female patients of childbearing potential who are heterosexually active and male patients with female sexual partners of childbearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the GPS treatment and for 4 months following the last dose of GPS, or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as the absence of menstrual periods for 12 consecutive months.
- Patients must not have end stage renal disease.
- Patients must have adequate hepatic function defined as a serum total bilirubin <2 × ULN (except for Gilbert'ssyndrome, which will allow bilirubin ≤3.0 mg/dL), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN.
- Patients must be willing and able to return to the clinical site for adequate follow-up and to comply with the EAP treatment schedule, as required.
Who cannot join
- Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF) or filgrastim (granulocyte colony stimulating factor [G-CSF]).
- Patients with acute promyelocytic leukemia (APL) or any morphologic and molecular variants, inclusive.
- Patients with a serious concurrent illness that in the opinion of the Treating Physician would pose an undue risk to the patient.
- Patients who currently have central nervous system leukemia.
- Patients who have received a live vaccine within 30 days prior to the first dose of EAP drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Vaccines used for the prevention of COVID-19 are allowed to be used as they are not live vaccines.
- Patients currently receiving systemic immunosuppressive therapy in dosing exceeding 10 mg daily of prednisone equivalent. The use of physiologic doses of corticosteroids or other immunosuppressive agents may be approved after consultation with the Sponsor. Steroids taken as short-term therapy (≤ 7 days) for antiemesis are permissible as are steroids with low systemic bioavailability (e.g., budesonide).
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- Patients who have a known additional malignancy that is progressing or has required active treatment within the past 5 years, even if currently inactive or unapparent.
- Patients who have a known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during EAP screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of treatment.
- Patients who had a previous clinically significant systemic allergic reaction to Montanide, sargramostim (GMCSF), or filgrastim (G-CSF).
- Patients who have an active life-threatening infection requiring systemic therapy.
- Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that is not in the best interest of the patient to participate, in the opinion of the Treating Physician. This includes any serious, intercurrent, chronic, or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the Treating Physician as an unwarranted high risk for investigational drug treatment.
- Patients who have a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the EAP.
- Patients who are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the EAP, starting with the screening visit through 30 days after the last dose of EAP treatment.
- Patients who have had an allogeneic solid organ transplant.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Single patient expanded access program to provide galinpepimut-S for eligible patients with AML or MDS who have no other treatment option.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Galinpepimut-S
- Keywords
- blood cancer, blood-forming cells, bone marrow, Wilms Tumor-1 protein, immunizing therapy, hematological malignancies
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galinpepimut-SBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Sellas Life Sciences Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593185
- Sponsor's protocol ID
- SLSG22-401 EAP
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT05593185
- Acronym / sponsor ID
- SLSG22-401 EAP
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- blood cancer, blood-forming cells, bone marrow, Wilms Tumor-1 protein, immunizing therapy, hematological malignancies
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Sellas Life Sciences GroupIndustry (pharma, biotech, devices)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single patient expanded access program to provide galinpepimut-S for eligible patients with AML or MDS who have no other treatment option.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosed with AML or MDS, as assessed by their Treating Physician;
- Have no appropriate, comparable, or satisfactory alternative treatment available, or such alternatives have been tried without clinical success, including clinical studies;
- Inability to participate in a GPS clinical study for the disease or conditions; and
- Have a treating physician who has appropriately evaluated the benefit/risk profile for potential GPS treatment.
- Patients must have a diagnosis of either AML or MDS.
Key exclusion criteria (14 listed)
- Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF) or filgrastim (granulocyte colony stimulating factor [G-CSF]).
- Patients with acute promyelocytic leukemia (APL) or any morphologic and molecular variants, inclusive.
- Patients with a serious concurrent illness that in the opinion of the Treating Physician would pose an undue risk to the patient.
- Patients who currently have central nervous system leukemia.
- Patients who have received a live vaccine within 30 days prior to the first dose of EAP drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Vaccines used for the prevention of COVID-19 are allowed to be used as they are not live vaccines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galinpepimut-S | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Galinpepimut-S in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Sellas Life Sciences Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Info at Sellas (+1 646-200-5278, clinicaltrialinfo@sellaslife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.