A Phase 1 Dose-escalation and Expansion Study of In Vivo BCMA-CAR T Cell Therapy (VV169) in Patients With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Vyriad, Inc.
Study ID
NCT07802717
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Multiple Myeloma Refractory
  • Multiple Myeloma in Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VV169 — BIOLOGICAL
    T-cell Targeted (CD3- targeted lentiviral vector)

Study Details

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.

Key Dates

First listed
Sep 3, 2026
Start date
Sep 8, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Active relapsed or refractory multiple myeloma with prior lines of treatment
    Dose Escalation
  • Experimental: Active relapsed or refractory multiple myeloma with no prior lines of treatment
    Dose Expansion

Primary Outcome Measure

Safety and tolerability of VV169 and determine the maximum tolerated dose [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Mayo ClinicRochesterMinnesota55901
Yi Lin, MD
Yi Lin, MD (PRINCIPAL_INVESTIGATOR)

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