Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Alfred Chung
Headshot of Alfred Chung
Alfred Chung

Description

Summary

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 4 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B), Monotherapy once every 4 weeks (Q4W) dosing (Arm E), Monotherapy once every 3 weeks (Q3W) dosing (Arm F). Arm A will evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of escalating doses of single-agent TNB-383B, administered Q3W, in approximately 73 participants. Once the maximum tolerated dose (MTD) or recommended phase 2 dose, (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 48 participants each. Dose A will be evaluated as a monotherapy Q4W, in Arm E to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 20 participants. Dose C will be evaluated as a monotherapy, in Arm F to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 25 participants.

Official Title

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

Keywords

Multiple Myeloma, TNB-383B, Plasma Cell Neoplasms

Eligibility

Locations

  • UCSF (UCSF) - Parnassus Heights /ID# 238680
    San Francisco California 94143 United States
  • Mayo Clinic - Rochester /ID# 238683
    Rochester Minnesota 55905-0001 United States

Lead Scientist at UCSF

  • Alfred Chung
    Dr. Alfred Chung is a hematologist-oncologist who cares for patients with blood cancers, including leukemias, lymphomas and myelomas. He sees patients who are in the hospital for treatment, including those who need a bone marrow transplant and those receiving chemotherapy or cellular therapies to bolster the immune system.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TeneoOne Inc.
ID
NCT03933735
Phase
Phase 1/2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
About 220 people participating
Last Updated