Expanded Access Program for Galinpepimut-S in Patients with AML or MDS

Inclusion Criteria

• Diagnosed with AML or MDS.
• No other suitable treatment options available, or previous treatments have not been successful.
• Unable to join a clinical study for Galinpepimut-S.
• Have a doctor who has evaluated the potential benefits and risks of Galinpepimut-S treatment.
• Must be 18 years or older.
• Able to communicate well with the doctor and understand the program requirements.
• Willing to sign an informed consent form.
• For AML patients, must have had a stem cell transplant after achieving remission.
• For MDS patients, a complete remission before transplant is not required.
• Must be within 30-120 days post-stem cell transplant.
• May receive other treatments like HMA, venetoclax, or FLT3 ITD agents alongside Galinpepimut-S.
• Must have a performance status score of 0, 1, 2, or 3, indicating varying levels of activity.
• Expected to live more than 6 months.
• Women must be postmenopausal or surgically sterile, or use effective contraception.
• Must not have end-stage kidney disease.
• Must have adequate liver function.
• Willing to return for follow-up visits and comply with the treatment schedule.

Exclusion Criteria

• Allergic reactions to Montanide, sargramostim, or filgrastim.
• Have acute promyelocytic leukemia (APL).
• Have a serious illness that poses a high risk.
• Have central nervous system leukemia.
• Received a live vaccine within 30 days before starting treatment.
• On high-dose immunosuppressive therapy.
• Have another active cancer needing treatment in the past 5 years.
• Have active brain metastases or carcinomatous meningitis.
• Have a life-threatening infection needing treatment.
• Have a condition or illness that makes participation risky.
• Have a psychiatric or substance abuse disorder affecting cooperation.
• Pregnant or breastfeeding, or planning to conceive during the program.
• Have had an organ transplant.