The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.
This trial is currently open and accepting patients.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Enrollment: 146 patients (estimated)View More
December 10, 2022
32 patients received tec-dara-len (0.72 mg/kg, n=13; 1.5 mg/kg, n=19). At the data cutoff (July 11, 2022), median follow-up was 5.78 months (mo; range, 1.0–10.4) and median treatment duration was 4.98 mo (range, 0.10–10.35). Median age was 62 years (range, 38–75); 87.5% were male. All patients had received prior MM treatment; median prior LOT was 2 (range, 1–3), and 31.3% were anti-CD38 exposed. The most frequent AE was CRS (81.3% [n=26]). All CRS events were grade 1/2, and 95% of the events occurred during cycle 1 treatment doses. Median time to onset was 2 days (range, 1–8) and median duration was 2 days (range, 1–22). No ICANS events were reported. Other frequent AEs (≥25.0% across both dose levels) were neutropenia (75.0% [n=24]; grade 3/4: 68.8% [n=22]), fatigue (43.8% [n=14]; grade 3/4: 6.3% [n=2]), diarrhea (37.5% [n=12]; all grade 1/2), insomnia (31.3% [n=10]; grade 3/4: 3.1% [n=1]), cough (28.1% [n=9]; all grade 1/2), hypophosphatemia (25.0% [n=8]; all grade 1/2), and pyrexia (25% [n=8]; grade 3/4: 6.3% [n=2]). The frequency of febrile neutropenia was 12.5% (n=4). Infections occurred in 24 patients (75.0%; grade 3/4: 28.1% [n=9]). The most common infections were upper respiratory infection (21.9% [n=7]), COVID-19 (21.9% [n=7]), and pneumonia (21.9% [n=7]). Three patients (9.4%) had COVID-19 pneumonia. One patient (3.1%) discontinued due to an AE (COVID-19) considered unrelated to study drugs; this patient died due to COVID-19. The overall response rate (ORR) was 13/13 evaluable patients (median follow-up, 8.61 mo) at 0.72 mg/kg and 13/16 evaluable patients (median follow-up was less mature at 4.17 mo) at 1.5 mg/kg. Very good partial response or better was achieved in 12 patients at the 0.72 mg/kg dose and was not mature for the 1.5 mg/kg group. Median time to first response was 1.0 mo (range, 0.7–2.0). Preliminary pharmacokinetic concentrations of tec in combination with dara-len were similar to those seen with tec monotherapy. Tec-dara-len treatment led to proinflammatory cytokine production (induction of interleukin-6, soluble interleukin-2Rα, interferon-γ, and tumor necrosis factor-α) and T-cell activation (upregulation of programmed cell death protein-1 and CD38 on peripheral T cells).
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