T Cells (EAGD T-Cells) after Stem Cell Transplantation and Post-transplant Cyclophosphamide for the Treatment of Blood Cancers

Inclusion Criteria

• PARTICIPANT ELIGIBILITY CRITERIA
• Able to give informed consent and have understanding of the investigational nature of the study
• Participants >= 18 years of age, with physician discretion of upper age limit
• Negative test for donor‐specific antibody within 28 days of starting conditioning regimen
• Hematopoietic cell transplant comorbidity index (HCT‐CI) =< 3 and > 3 at discretion of principal investigator (PI). Note: Exception may be made on individual cases after discussion with and approval from the principal or treating investigator
• High resolution HLA typing for HLA‐A, B, C and DRB1
• Haploidentical donor identified and consented
• Negative screening tests for human immunodeficiency virus (HIV)‐I and II, West Nile virus (WNV), hepatitis B and C viruses, treponema pallidum. Nucleic acid testing (NAT) is performed for HIV‐1, HCV, and WNV
• Karnofsky performance score (KPS): >= 70
• Women of child‐bearing potential and men with partners of child‐bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for ONE YEAR following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately
• Men of child‐bearing potential must not father a child or donate sperm while on this study and for ONE YEAR after their last study treatment
• Participant has appropriate caregivers identified
• Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows. * Acute myeloid leukemia (AML) in morphologic complete remission with intermediate/high‐risk features (per National Comprehensive Cancer Network [NCCN] criteria or European LeukemiaNet [ELN] criteria) or relapsed disease per treating investigator * Chronic myeloid leukemia (CML) in any chronic phase * Myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) with intermediate/high risk features or refractory disease (with bone marrow blast count < 10%) * Acute lymphoblastic leukemia (ALL) in morphologic complete remission with high‐risk features or relapsed disease
• Normal left ventricular ejection fraction (LVEF) (50% or above) as measured by multigated acquisition scan (MUGA) or echocardiogram (should be done within 35 days prior to study registration)
• Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) should be 50% or above expected (should be done within 35 days prior to study registration)
• Serum creatinine level to be < 2 mg/dl AND estimated (Cockcroft‐Gault formula) or measured (takes priority if done) creatinine clearance (CrCl) must be equal or greater than 50 mL/min (should be done within 35 days prior to study registration)
• Serum bilirubin < 1.5 x upper limit of normal (ULN) (should be done within 35 days prior to study registration)
• Aspartate transaminase (AST) < 2.5 x ULN (should be done within 35 days prior to study registration)
• Alanine transaminase (ALT) < 2.5 x ULN (should be done within 35 days prior to study registration)
• Alkaline phosphatase < 2.5 x ULN (should be done within 35 days prior to study registration)
• DONOR ELIGIBILITY CRITERIA
• All potential donors, irrespective of participation in this clinical trial will also sign the standard donor informed consent form prior to stem cell donation
• Must have adequate peripheral venous access
• High resolution HLA typing for HLA-A, B, C and DRB1
• No physical exam or laboratory findings that, in the opinion of the investigator, make the patient ineligible for hematopoietic stem cell transplantation
• Negative screening results for the following: * HIV‐I * HIV-II * WNV * Hepatitis B virus * Hepatitis C virus * Treponema pallidum * Nucleic acid testing (NAT) for HIV-1 * NAT for HCV * NAT for WNV
• PARTICIPANT PRE‐EAGD INFUSION CRITERIA
• Neutrophil engraftment as evidenced by three consecutive days of ANC >= 500 per uL (within 48 hours prior to infusion of the EAGD T cell product)
• No uncontrolled infection with sepsis syndrome (e.g. persistent positive blood culture) (within 48 hours prior to infusion of the EAGD T cell product)
• No hemodynamic instability (due to sepsis or organ dysfunction) or circulatory volume overload (within 48 hours prior to infusion of the EAGD T cell product)
• No clinically significant organ toxicity defined as follows: * No active heart failure or clinical fluid overload. * No elevated total bilirubin ≥ 1.5 upper normal level (unless indirect hyperbilirubinemia attributed to non‐hepatic pathology), or elevated liver enzymes (ALT, AST, alanine phosphatase [ALP]) > 5 x ULN * No hypoxemia requiring oxygen therapy * No active acute or chronic graft versus host disease (any grade) and less than 12 months from prior transplant.

Exclusion Criteria

• No active central nervous system (CNS) neoplastic involvement
• No morbid obesity with body mass index > 35 (borderline cases may be considered on case‐ by‐case basis after discussion with the primary investigator)
• Not HIV1 (human immunodeficiency virus‐1) or HIV2 positive
• No current or anticipated use of other investigational agents while participating in this study
• No psychiatric illness/social situations that would limit compliance with study requirements
• Not pregnant or breastfeeding. There is a potential for congenital abnormalities and for this regimen to harm breastfeeding infants (if applicable)
• Life expectancy is not less than 12 weeks
• No unstable medical condition that, in the opinion of the investigator, may increase risks of study procedures and/or assessments
• No known allergy to DMSO or contraindication to GCSF or its constituent ingredients for donors undergoing mobilization