STR-P004 / Starna Therap - LARVOL DELTA

In vivo CD19 CAR T-cell therapy (STR-P004) to induce remission in patients with autoimmune diseases (AID). (ASCO 2026) - P=N/A | "STARNA's STR-P004 utilizes a proprietary LNP platform to deliver anti-CD19 CAR mRNA intravenously, generating functional CAR-T cells directly in vivo, thereby improving accessibility. STR-P004, an off-the-shelf, repeatable therapy, demonstrated favorable safety and initial efficacy in AID, particularly for patients requiring continuous immunosuppression."

CAR T-Cell Therapy • IO biomarker • Preclinical • Alopecia • Glomerulonephritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • CD8 • IL6

IN VIVO CD19 CAR-T CELL THERAPY (STR-P004) INDUCES REMISSION IN PATIENTS WITH AUTOIMMUNE DISEASES. (EHA 2026) - "STARNA's STR-P004 utilizes a proprietary LNP platform to deliver anti-CD19 CAR mRNA intravenously, generating functional CART cells directly in vivo, thereby improving accessibility.Aims: To develop and validate a targeted LNP-based,CD19-directed in vivo CART therapy for AID.STR-P004 integrates optimized mRNA into tissue and cell-selective LNPs.Its formulation contains a lead ionizable lipid,conjugated with a CD8-targeting ligand and anti-CD19 CAR mRNA.Adult AID patients received up to 8 doses via a TITE-BOIN12 design across three levels: de-escalation (0.03 mg/kg), starting (0.05 mg/kg), and DL2 (0.1 mg/kg), with systematic safety and efficacy evaluation.Preclinically,STR-P004 induced efficient CAR expression on CD8?T cells, enabling deep B-cell depletion and prolonged survival.In non-human primates, it showed a favorable safety profile with only transient liver enzyme elevations and cytokine release.No anti-PEG antibodies were detected.Between September1,2025,and..."

CAR T-Cell Therapy • IO biomarker • Preclinical • Alopecia • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Renal Disease • CD8 • IL6

Exploratory Clinical Study on the Safety of STR-P004 (clinicaltrials.gov) - P=N/A | N=39 | Recruiting | Sponsor: Beijing GoBroad Hospital | Not yet recruiting ➔ Recruiting | Trial primary completion date: Mar 2026 ➔ Aug 2026

Enrollment open • Trial primary completion date • Immunology

An early clinical study to evaluate the safety and clinical efficacy of STR-P004 in subjects with relapsed/refractory CD19-positive acute lymphoblastic leukemia (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

New trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

To Evaluate the Safety and Tolerability of STR-P004 for the Treatment of Immune-mediated Kidney Diseases (clinicaltrials.gov) - P=N/A | N=9 | Not yet recruiting | Sponsor: Starna Therapeutics

New trial • Immunology • Nephrology • Renal Disease

To Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of STR-P004 (clinicaltrials.gov) - P=N/A | N=11 | Not yet recruiting | Sponsor: Starna Therapeutics

New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Exploratory Clinical Study on the Safety of STR-P004 in the Treatment of Patients With Relapsed or Refractory Autoimmune Diseases (clinicaltrials.gov) - P=N/A | N=39 | Not yet recruiting | Sponsor: Beijing GoBroad Hospital

New trial • Immunology

A Study to Evaluate the Safety and Clinical Efficacy of STR-P004 (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Starna Therapeutics

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology