VBP101 Clinical Trial
VBP101, a Phase 1/2a clinical trial for patients with CD33-positive AML who are at high risk of relapse, is actively enrolling patients. Participants (18-70 years old) must have a diagnosis of CD33+ AML, an HLA-matched (10/10) related or unrelated donor, and be a candidate for a hematopoietic stem cell transplant (HCT). The primary goals of the trial are to evaluate tolerability and feasibility of the trem-cel stem cell transplant, with a focus on confirming that trem-cel (VOR33) can engraft normally.
Following engraftment, patients will be eligible for treatment with Mylotarg, a CD33-directed targeted therapy, to potentially extend leukemia-free survival and to provide evidence that transplant with trem-cel protects normal blood cells from the count-suppressing side effects of Mylotarg.
More information on the VBP101 study, including participating centers, can be found here.
VBP301 Clinical Trial
The FDA has cleared Vor Bio’s Investigational New Drug (IND) application for VCAR33ALLO, a CAR-T cell therapy derived from allogeneic healthy donors that targets the CD33 protein. VCAR33ALLO is being studied in the VBP301 clinical trial, which will focus on patients aged 18 and older who have relapsed following an allogeneic stem cell transplant, including patients who have received trem-cel. This trial uses T cells harvested from the original donor as the starting material for the drug product.
Mylotarg, an Antibody Drug Conjugate (ADC), is currently the only anti-CD33 therapy approved by the FDA. We believe that our CAR-T product candidate, VCAR33ALLO, may ultimately be a better targeted therapy due to higher expected potency and longer expected persistence.
More on the VBP301 study, including participating centers, can be found here.
Vor Bio is working with clinical trial investigators at leading transplant and cancer centers in the U.S. and Canada with close oversight from the U.S. Food & Drug Administration (FDA) and Health Canada, as well as an independent data safety monitoring committee. Together, these groups provide rigorous supervision to ensure patient and donor safety
Joining a clinical trial
Clinical trials are highly regulated by the US Food and Drug Administration and other governmental regulatory agencies for the safety of patients and for the validity of the data. Vor Bio cannot help you in any way get into a trial. We can, however, direct you to information about the trial and to the clinical investigators who are managing the trial at the various transplant centers.