PIT565 / Novartis - LARVOL DELTA

A Phase 1 Study of PIT565, a First-in-Class, Anti-CD3, Anti-CD19, Anti-CD2 Trispecific Antibody in Patients with Relapsed and/or Refractory B-Cell Malignancies (ASH 2023) - P1 | "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."

Clinical • P1 data • Trispecific • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Dermatology • Endocrine Disorders • Hematological Malignancies • Immunology • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Psoriasis • Vitiligo • CD58 • CD8

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=57 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=57 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A phase Ib, open-label, ascending dose study with step-up doses to assess safety, tolerability, and pharmacokinetics of PIT565 in participants with systemic lupus erythematosus (SLE) (ChiCTR) - P=N/A | N=66 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Novartis Pharmaceuticals (NVS.US)'s Class 1 new drug approved for clinical use in rheumatoid arthritis [Google translation] (163.com) - "Zhitong Finance APP learned that on May 8, the CDE official website showed that Novartis Pharmaceuticals...Class 1 new drug PIT565 was approved for clinical use for rheumatoid arthritis."

New trial • Rheumatoid Arthritis

Novartis (NVS.US) triple-antibody new drug approved again in China for clinical use in systemic lupus erythematosus [Google translation] (Sina Corp) - "The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration shows that Novartis....has obtained an implicit approval for a new clinical trial for its Class 1 new drug PIT565, which is intended to be developed to treat systemic lupus erythematosus (SLE)."

New trial • Systemic Lupus Erythematosus

An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2027 ➔ Jul 2027 | Trial primary completion date: Nov 2027 ➔ Jul 2027

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jul 2028 ➔ Nov 2027 | Trial primary completion date: Jul 2028 ➔ Nov 2027

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2026 ➔ Jun 2028

Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

POSTER HIGHLIGHT: A First-in-Class Anti-CD19, Anti-CD3, Anti-CD2 Trispecific Antibody (PIT565) for the Treatment of B Cell Malignancies (IO-SUMMIT EUROPE 2023) - No abstract available

Trispecific • Oncology

A First-in-Class Anti-CD19, Anti-CD3, Anti-CD2 Trispecific Antibody (PIT565) for the Treatment of B Cell Malignancies (IO-SUMMIT EUROPE 2023) - No abstract available

Trispecific • Oncology

PIT565, a First-in-Class Anti-CD19, Anti-CD3, Anti-CD2 Trispecific Antibody for the Treatment of B Cell Malignancies (ASH 2022) - P1 | "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."

IO biomarker • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD58

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Aug 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19