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 developed by Novartis AG (ticker NVS). It is being studied in Phase 1 clinical trials for B-cell Non-Hodgkin Lymphoma, rheumatoid arthritis, and systemic lupus erythematosus. It has not been approved by the FDA and remains in clinical development.
PIT565 is being evaluated for B-cell Non-Hodgkin Lymphoma (B-NHL), rheumatoid arthritis, and systemic lupus erythematosus (SLE). All three indications are in Phase 1 testing. The B-NHL program also includes B-cell Acute Lymphoblastic Leukemia. No approved use exists for PIT565 at this time.
PIT565 is developed by Novartis AG, which trades under the ticker NVS. Novartis is running the Phase 1 clinical program for the monoclonal antibody across oncology and autoimmune indications, including B-cell Non-Hodgkin Lymphoma, rheumatoid arthritis, and systemic lupus erythematosus.
PIT565 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. Three Phase 1 dose-escalation studies are active, covering B-cell malignancies, rheumatoid arthritis, and systemic lupus erythematosus. No later-phase trials have been completed.
PIT565 is being studied in three active Phase 1 trials. NCT05397496 tests it in relapsed or refractory B-cell malignancies, including B-cell Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. NCT07029555 is in rheumatoid arthritis, and NCT06335979 is in systemic lupus erythematosus. All three are active but not recruiting.