A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Aug 24, 2025
  • participants needed
    169
  • sponsor
    TeneoOne Inc.
Updated on 22 April 2022
calcium
bone marrow transplant
measurable disease
bone marrow procedure
neutrophil count
tumor cells
serum calcium
daratumumab
refractory multiple myeloma
immunomodulatory imide drug
bcma

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 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of escalating doses of single-agent TNB-383B, administered once every 3 weeks (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 subjects each.

Details
Condition Multiple Myeloma
Treatment TNB-383B
Clinical Study IdentifierNCT03933735
SponsorTeneoOne Inc.
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 (e.g., daratumumab)
Must have adequate bone marrow function as defined in the protocol
Must have an estimated glomerular filtration rate >= 30 mL/min as estimated by the Modification of Diet in Renal Disease formula
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)
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)
Has confirmed evidence of relapse/progression from the immediately prior MM therapy
or participant is relapsed/refractory to the immediately prior MM therapy
Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival bone marrow tumor tissue that was collected within 6 months prior to screening and without intervening treatment
Serum calcium (corrected for albumin) at or below the ULN range

Exclusion Criteria

Has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of basal cell or squamous cell carcinoma of the skin, in situ malignancy, low-risk prostate carcinoma after curative therapy, or complete resection/curative therapy of an advanced malignancy
History of central nervous system involvement by their myeloma
History of Grade ≥ 3 peripheral neuropathy
History of plasma cell leukemia, POEMS syndrome, or amyloidosis
Has received another investigational drug within 21 days of enrollment
Has ever received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded
Has received a autologous stem cell transplant within 12 weeks or an allogeneic stem cell transplant within 1 year of the first dose of study drug treatment
Has any medical or psychiatric condition which in the opinion of the investigator or study Medical Monitor places the participant at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of participant safety or study results
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
Has known active infection Grade >= 2 requiring anti-infective treatment
Has a history of major cardiac abnormalities
Has unresolved AEs as defined in the protocol
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