PIT565

P1, N=54, Recruiting, Novartis Pharmaceuticals | N=32 --> 54

P1, N=61, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2028 --> May 2026 | Trial primary completion date: Jun 2027 --> May 2026

P1, N=61, Active, not recruiting, Novartis Pharmaceuticals | N=140 --> 61

P1, N=140, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

P1, N=57, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

P1, N=57, Not yet recruiting, Novartis Pharmaceuticals

P1, N=54, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Nov 2027 --> Jul 2027 | Trial primary completion date: Nov 2027 --> Jul 2027

P1, N=54, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2028 --> Nov 2027 | Trial primary completion date: Jul 2028 --> Nov 2027

P1, N=60, Not yet recruiting, Novartis Pharmaceuticals

P1, N=140, Recruiting, Novartis Pharmaceuticals | Trial completion date: Feb 2026 --> Jun 2028 | Trial primary completion date: Feb 2025 --> Jun 2027

Patients with contraindication to tocilizumab; history of other malignant disease; active central nervous system involvement; autoimmune disease (other than patients with vitiligo, hypothyroidism only requiring hormone replacement, or psoriasis not requiring systemic treatment or conditions not expected to recur); or receiving systemic treatment with any immunosuppressive medication are not eligible. The dose escalation phase is guided by an adaptive Bayesian logistic regression model following the escalation with overdose control principle. The MTD and/or RD are further explored during the dose-expansion phase.

P1, N=140, Recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2025 --> Feb 2026 | Trial primary completion date: Aug 2024 --> Feb 2025