PIT565

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

The robust expression of the CD19 antigen in ALL and NHL has resulted in the development of highly effective therapeutics targeting CD19 by leveraging redirected T cells, which include the bispecific T-cell engager blinatumomab and CD19-directed CAR-T therapies axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. Taken together, the findings from the preclinical studies suggest that PIT565 may achieve deeper and more durable responses compared to competitor CD3 bispecifics. First-in-human trial of PIT565 (NCT05397496) has been initiated and will be conducted in patients who are diagnosed with relapsed and/or refractory adult NHL after receiving two or more lines of chemotherapy and patients with relapsed and/or refractory B-ALL.

P1, N=140, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

P1, N=140, Not yet recruiting, Novartis Pharmaceuticals