AVM Biotechnology Inc
This is an open-label, Phase 1/2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.
Phase 2 For Phase 2, one or more patient cohort(s) will receive repeat RP2D infusions in 21 day intervals until intolerance, unacceptable toxicity or disease progression, to determine the number of repeat infusions that are safe, effective and tolerable in this patient population. PK assessments will be made at sites participating in both Phase 1 and Phase 2 after each repeat infusion for the first 6 patients enrolled into each repeat dosing cohort. Full PK assessments will be made as per Phase 1 after the 1st (first) and 6th (sixth) repeat infusions, while for the second to fifth doses (2nd t…
Inclusion Criteria: * 1\. Age ≥12 years and weight ≥40 kg; 2\. Histologically confirmed diagnosis per 2016 World Health Organization (WHO) classification of lymphoid neoplasms160 and per the 2016 WHO classification of acute leukemia161 of the following indications: * DLBCL, including arising from follicular lymphoma; * High-grade B-cell lymphoma; * MCL; * Primary mediastinal large B-cell lymphoma; * Primary DLBCL of the CNS; * Burkitt or Burkitt-like lymphoma/leukemia; * CLL/SLL; or * B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymph…
Intravenous infusion over \~1 hours