Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PIT565 · 3 trials · 4 indications
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Safety assessments of PIT565 including changes in vital signs, electrocardiograms (ECG) and laboratory results from baseline
Assessment of safety of study drug. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of CTCAE grade 3 or higher that occurs within the DLT evaluation period (28 days or 35 days depending on the schedule) and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with exceptions provided in the clinical protocol.
Assessment of tolerability of study drug
Assessment of tolerability of study drug
Assessment of tolerability of study drug Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.
| Arm | Type | Description |
|---|---|---|
| PIT565 dose 1 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 2 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 3 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 4 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 5 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 6 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 7 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 8 | EXPERIMENTAL | Study treatment will be provided in vials as open-label participant specific supply. |
| Cohort 1 | EXPERIMENTAL | Dose level 1 |
| Cohort 2 | EXPERIMENTAL | Dose level 2 |
| Cohort 3 | EXPERIMENTAL | Dose level 3 |
| Cohort 4 | EXPERIMENTAL | Dose level 4 |
| Cohort 5 | EXPERIMENTAL | Dose level 5 |
| Cohort 6 | EXPERIMENTAL | Dose level 6 |
| Cohort 7 | EXPERIMENTAL | Dose level 7 |
| Cohort 8 | EXPERIMENTAL | Dose level 8 |
| PIT565 Group A (dose escalation part) | EXPERIMENTAL | PIT565 in adult NHL patients for whom two or more lines of chemotherapy have failed and either having progressed (or relapsed) after autologous hematopoietic stem cell transplantation (HSCT), or being ineligible for or not consenting to the procedure |
| PIT565 Group B (dose escalation part) | EXPERIMENTAL | PIT565 in adult R/R ALL patients. |
| PIT565 Group A1 (dose expansion part) | EXPERIMENTAL | PIT565 Recommended dose 1 (RD1) in adult R/R large B-cell lymphoma (LBCL) (DLBCL, double/triple hit High-grade B-cell lymphoma (HGBCL), Primary mediastinal large B-cell lymphoma (PMBCL), Follicular lymphoma grade 3B (FL3B)) patients. |
| PIT565 Group A2 (dose expansion part) | EXPERIMENTAL | PIT565 RD2 in adult R/R LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients. |
| PIT565 Group B1 (dose expansion part) | EXPERIMENTAL | PIT565 in adult R/R ALL patients. |
| Name | Type | Description |
|---|---|---|
| PIT565 | BIOLOGICAL | Study treatment will be provided in vials as open-label participant specific supply. |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. Male and female patients, aged 18 to 75 years at screening, diagnosed with RA according to the 2010 ACR/EULAR or 1987 ACR classification at least 12 weeks prior to screening. * Immunization (primary ...
PIT565 is an investigational monoclonal antibody being studied for autoimmune and oncologic conditions. In clinical trials, it is being evaluated for Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis, and B-cell Non-Hodgkin Lymphoma (B-NHL). It is also being studied in B-cell Acute Lymphoblastic Leukemia (B-ALL) in one trial.
PIT565 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is sponsoring multiple Phase 1 clinical trials of PIT565 across different indications.
PIT565 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three ongoing trials are Phase 1 studies, and none have been completed yet.
PIT565 is being studied in three active Phase 1 trials. NCT05397496 is evaluating it in relapsed and/or refractory B-cell malignancies, including B-NHL and B-ALL. NCT06335979 is an ascending dose study in Systemic Lupus Erythematosus. NCT07029555 is an ascending dose study in Rheumatoid Arthritis.
PIT565 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its effects on B-cell mediated diseases, including autoimmune conditions like SLE and Rheumatoid Arthritis, as well as B-cell malignancies.
PIT565 is the only name provided for this investigational drug. No alternative names or aliases have been reported in the clinical trial information. It is a distinct investigational compound being developed by Novartis.