Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT

Exclusion Criteria

• •1. Active acute or chronic graft versus host disease (GvHD)
• •1. Eligible patients will not be on any steroids ≥10 mg per day prednisone or equivalent or other immunosuppressants such as tacrolimus, cyclosporine, etc.
• •2. Intermittent topical, inhaled or intranasal corticosteroids are allowed
• •2. Have active or uncontrolled infections with positive cultures and/or requiring treatment with IV anti-infective agents
• •3. History of clinically significant cardiovascular disease including but not limited to:
• •1. Myocardial infarction or unstable angina within the 6 months prior to the initiation of study
• •2. Stroke or transient ischemic attack within 6 months prior to initiation of study
• •3. Clinically significant cardiac arrhythmia
• •4. Uncontrolled hypertension: systolic blood pressure (SBP) \> 180 mmHg, diastolic blood pressure (DBP) \> 100 mmHg
• •5. Congestive heart failure (New York Heart Association \[NYHA\] class III-IV)
• •6. Pericarditis or clinically significant pericardial effusion
• •7. Myocarditis
• •4. Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
• •5. History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus erythematosus, etc.) resulting in end organ injury or requiring systemic immunosuppression / systemic disease modifying agents within the last 2 years prior to enrollment. Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and subjects with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for the study
• •6. Human immunodeficiency virus (HIV) seropositive; HIV testing within 2 years of enrollment
• •7. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). Patients who are hepatitis B surface antigen (HBsAg) negative and HBV viral DNA negative are eligible
• •1. Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible
• •2. Patients who are seropositive because of HBV vaccine are eligible
• •8. Seropositive for and with active viral infection with hepatitis C virus (HCV)
• •a. Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible
• •9. Second primary invasive malignancy that has not been in remission for greater than 2 years. Exceptions that do not require a 2-year remission include: resected non-melanoma skin cancer; carcinoma in situ (cervix, bladder, breast, etc.) or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score \< 6); or resected melanoma in situ
• •10. History of trauma or major surgery within 4 weeks prior to the study enrollment
• •11. Any serious underlying medical or psychiatric condition that would impair the ability of the patient to receive or tolerate the planned treatment and follow up
• •12. Known hypersensitivity to any component of NEXI-001 T cells, cyclophosphamide, fludarabine or tocilizumab
• •13. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment. Inactivated annual influenza vaccination is allowed.
• •14. Dementia or altered mental status that would preclude understanding and rendering of informed consent
• •15. History of seizures, aphasia, psychosis or other chronic clinically significant neurologic disorders
• •a. Patients with remote history of seizures that are well controlled on anti-seizure medications and without any seizure episode for 6 months are eligible
• •16. Any issue that in the opinion of the investigator, would contraindicate the patient's participation in the study or confound the results of the study