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

Open to people ages 18 years and up

• 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.