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.
Eligible patients will be recruited into either the dose escalation phase or dose expansion phase. Eligible patients will be adults who have received prior therapy, or are ineligible for, or did not tolerate standard approved treatment and have no available therapies open to them are eligible. Additional patients will be recruited in the expansion phase once an optimal dose has been identified. In the expansion phase, T cell engagers therapies and anti-BCMA ADC \> 6 months prior, and CAR-T therapy received \> 9 months prior to study enrollment will be permitted.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
T-cell Targeted (CD3- targeted lentiviral vector)
The Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGSafety and tolerability of VV169 and determine the maximum tolerated dose
Assess incidence, type and severity of AEs, SAEs, DLTs, and clinically relevant laboratory abnormalities.
Time frame: 2 years
Determine the recommended phase 2 dose of VV169
Incidence of DLTs and SAEs per dose level in dose escalation phase.
Time frame: 28 days post last patient last dose in the Dose Escalation phase.
Anti-tumor activity of the in vivo generated BCMA+ CAR-T cells
Objective Response Rate
Time frame: 2 years
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