TNB-383B is a bi-specific antibody, meaning that it interacts with two molecules in your body. One molecule is called B-Cell Maturation Antigen (BCMA) and is found on your multiple myeloma cells. The second is called CD3 and is present on your killer T-cells. When CD3 is engaged on a T cell, it turns the T-cell on and makes it kill whatever cell triggered the activation. Because TNB-383B sticks very strongly to the BCMA on your myeloma cells, nearby T-cells should specifically attack your tumor cells.
This study is open-label, meaning that everyone on the study will receive TNB-383B. It is a Phase 1, First-in-Human trial, meaning that it is the first study where TNB-383B will be given to human patients. TNB-383B is an investigational agent, meaning that it is still being tested for safety and efficacy and has not yet been approved by the FDA.
The purpose of the Study is:
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
You may be eligible to participate in this study if you:
The following is a listing of trial locations that are open and accepting patients.
December 06, 2020
A novel BCMA and CD3 targeted bispecific T-cell engaging immunotherapy agent TNB-383B has demonstrated significant responses at higher dose levels and tolerability at all dose levels, including mild cases of cytokine release syndrome (CRS), according to initial results of a phase 1 trial (NCT03933735) presented during the 2020 American Society of Hematology (ASH) Annual Meeting.
CRS was the most common adverse event (AE) reported on the study and was observed in 45% of patients at any grade, which increased to 80% in patients who received doses ≥40 mg, but cases were grade 1/2. The median onset to CRS was less than a day (range, 0-7) and the median duration was 1 day (range, 1-7). Five patients were treated with tocilizumab. Only 1 patient had a reoccurrence of CRS.
Other common AEs included fatigue (24%), headache (22%), infection (21%), nausea (21%), and anemia (21%). The most common grade ≥3 AEs were anemia (17%), neutropenia (16%), thrombocytopenia (14%), and infection (14%). Treatment-related AEs increased at higher doses ≥40 mg due to increased CRS, but there was no significant increase observed in the incidence of other AEs with higher doses of treatment.
The objective response rate (ORR) at lower doses (0.025 to 1.8 mg; n = 15) was 20%, with a complete response (CR) rate or better of 6.7%. At doses from 5.4 to 30 mg (n = 28), the ORR was 43% with a CR or better rate of 17.9%. The ORR was 80% at higher dose levels (40 to 60 mg; n = 15) with a CR or better rate of 13.3%. Three of 4 patients evaluable for minimal residual disease were found to be negative.
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