Clinical Trial Enrollment
AVM Biotechnology is actively enrolling patients in the AVM0703-001 or “WWRD” study, an open-label, adaptive design expansion, cohort pivotal Phase 1/2 study in Relapsed/Refractory Non-Hodgkin’s Lymphoma and leukemia at major cancer treatment centers in the US. The study design is intended for participants who have not responded to prior therapies. To date the drug has been well tolerated, without any significant adverse events reported.
Phase 1 is the tolerability and dose-finding portion while Phase 2 is intended to determine efficacy in this difficult patient population. It is believed that AVM0703 can induce remission or sufficiently improve a patient’s condition so they may tolerate other treatments, such as hematopoietic cell transplantation (HSCT) or cell therapy protocols.
The focus of this study includes patients with a variety of lymphomas/leukemias such as:
- lymphomas, i.e., mantel cell lymphoma (MCL)
- primary mediastinal large B-cell lymphoma (PMBL)
- Burkitt or Burkitt-like lymphoma/leukemia
- chronic and small lymphocytic leukemias (CLL/SLL)
- B-lymphoblastic leukemia/lymphoma
- T-lymphoblastic leukemia/lymphoma
- acute leukemia/lymphoma
- acute leukemias of ambiguous lineage
- natural killer (NK) cell lymphoblastic leukemia/lymphoma.
More information can be found here on ClinicalTrials.gov, NCT04329728.
The company has also received permission to proceed with a clinical trial in treating patients with Acute Respiratory Distress Syndrome (ARDS) whether due to Influenza, COVID-19, or injury. This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening ARDS . The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients. This study is not yet enrolling.
More information can be found on ClinicalTrials.gov, NCT04366115
Patients who do not meet requirements for this clinical trial may be eligible for AVM0703 via AVM’s Compassionate Use or Expanded Access Program.
