Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation

Inclusion Criteria

• •Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) who are candidates for HDT-ASCT with one of the following conditioning regimens:
• •* carmustine, etoposide, cytarabine, melphalan (BEAM)
• •* cyclophosphamide, carmustine, etoposide (CBV)
• •* thiotepa, busulphan, cyclophosphamide (TBC)
• •* additional myeloablative chemotherapy-based conditioning regimens may be permitted with the approval of the medical monitor
• •Adjunct radiation therapy to HDT will be allowed.
• •Adequate organ function is required, defined as follows:
• •* Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
• •* AST, ALT, and alkaline phosphatase \< 3 times the upper limit of normal
• •* Creatinine clearance ≥ 40 ml/min (calculated by Cockcroft Gault)
• •* LVEF ≥ 45% by MUGA or resting echocardiogram
• •* Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
• •* Adequate performance status ECOG ≤1
• •For female subjects of childbearing potential:
• •* A negative serum or urine pregnancy test at screening.
• •* Subject must be willing to use a recommended method of contraception from the start of the screening period and throughout the study period.
• •For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
• •\- Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of conditioning therapy for at least 1 year after completion and discussion with a treating physician.
• •Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
• •Ability to provide written informed consent.