Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nina Shah
Photo of Nina Shah
Nina Shah

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 subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B ranging from 25 micrograms to 40 milligrams per dose, administered once every 3 weeks (Q3W), in approximately 24 subjects. 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, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the MTD/RP2D dose of TNB 383B monotherapy in approximately 48 subjects.

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 Neoplasms, Plasma Cell TNB-383B

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subjects with Relapsed/Refractory Multiple Myeloma.
  • Subject has received three or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide (IMiD) and an anti-CD38 monoclonal antibody (ie, daratumumab).
  • Subject has Measurable Disease, defined as at least 1 of the following:
  • Serum M-protein ≥ 0.5 g/dL (≥ 5 g/L)
  • Urine M-protein ≥ 200 mg / 24h
  • Serum free light chain (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/L) and an abnormal serum FLC ratio (< 0.26 or > 1.65).
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Prior bone marrow transplant is acceptable if subject is > 12 weeks (autologous) or > 1 year (allogeneic) status-post transplantation
  • Subject must have adequate bone marrow function, defined as:
  • absolute neutrophil count (ANC) ≥ 1000/mm3;
  • platelets ≥ 50,000/mm3;
  • hemoglobin ≥ 8.0 g/dL.
  • Subject must have an eGFR ≥ 30 mL/min as estimated by the MDRD formula.
  • Subject must have total bilirubin ≤ 1.5 × upper limit of normal (ULN; except if the subject has a known diagnosis of Gilbert's syndrome, in which case bilirubin must be < 3 x ULN).
  • Serum calcium (corrected for albumin) at or below the ULN range.

You CAN'T join if...

  • Subject has ever received BCMA-targeted therapy. Subjects who have received targeted therapy against non-BCMA targets will not be excluded
  • Subject has a history of central nervous system involvement by their myeloma.
  • Subject has a history of ≥ Grade 3 peripheral neuropathy.
  • Subject has a history of plasma cell leukemia, POEMS syndrome, or amyloidosis.
  • Subject has received any therapy to treat cancer or undergone a major surgical procedure within 21 days, or within 5 half-lives of an anticancer drug, prior to the first dose of study treatment, whichever is shorter.
  • Subject has a history of major cardiac abnormalities.
  • Subject has a known active infection requiring parenteral anti-infective treatment

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Mayo Clinic-Rochester accepting new patients
    Rochester Minnesota 55905 United States

Lead Scientist at UCSF

  • Nina Shah
    Dr. Nina Shah is a hematologist who specializes in the treatment of multiple myeloma, a type of cancer affecting the blood marrow. She treats patients at the Hematology and Blood Marrow and Transplant Clinic. Nina received a bachelor’s degree in cognitive neuroscience at Harvard University, followed by a medical degree from New York University School of Medicine.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Teneobio, Inc.
ID
NCT03933735
Phase
Phase 1
Study Type
Interventional
Last Updated