A Phase 1, first in human, study to evaluate the safety and the effects of in vivo BCMA-CAR T cell therapy (VV169) in patients with Multiple Myeloma that has been previously treated and has come back, or does not respond to standard treatments. Eligible patients will receive VV169, a T-cell targeted lentiviral vector, via infusion. Patients will be monitored for safety and tolerability for up to 2 years, until progressive disease or start of next treatment, whichever is earlier.
Able and willing to sign the informed consent form and comply with the protocol and the restrictions and assessments therein.
≥ 18 years of age.
Active relapsed or refractory multiple myeloma with at least 3 prior lines of therapy, OR ineligible for or did not tolerate standard approved treatment and have no available therapies open to them.
For Dose Escalation Phase: No prior T-cell engager therapies. No prior BCMA targeting antibody-drug conjugate (ADC) therapy. CAR-T therapy received ≥2 years prior to study enrollment is permitted.
Has monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis. Has Waldenstrom macroglobulinemia, primary amyloid light chains (AL) amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin abnormalities (POEMS) syndrome. Patients with secondary plasma cell leukemia or extramedullary myeloma disease are permitted.
Failed to recover from acute, reversible effects of prior therapy regardless of interval since last treatment.
Any of the following because this study involves an integrating lentiviral vector.
Pregnant
Sequential
VV169
Biological/VaccineT-cell Targeted (CD3- targeted lentiviral vector)
Safety and tolerability of VV169 and determine the maximum tolerated dose
Assess incidence, type and severity of AEs, SAEs, DLTs, and clinically relevant laboratory abnormalities.
Determine the recommended phase 2 dose of VV169
Incidence of DLTs and SAEs per dose level in dose escalation phase.
Anti-tumor activity of the in vivo generated BCMA+ CAR-T cells
Objective Response Rate
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Vyriad, Inc.
Lead sponsor
Mayo Clinic
Collaborator
