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

Overview

About this study

The purpose of this study is to evaluate the safety, clinical pharmacology and clinical activity of TNB-383B, a 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • 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 (i.e., 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.

Exclusion Criteria: 

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions