QT-019B / Qihan Biotech - LARVOL DELTA

A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Hangzhou Qihan Biotech Co., Ltd.

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

Qihan Biotech Initiates Dosing in Phase I/IIa Clinical Trial with Off-the-Shelf Allogeneic CAR-T Therapy for Refractory Systemic Lupus Erythematosus (Businesswire) - "The phase I/IIa clinical trial, QT-019B-001CN, is an open-label, single-arm, multicenter clinical study conducted in patients with rSLE."

Trial status • Systemic Lupus Erythematosus

Allogeneic dual-target CD19/BCMA CAR T-cell therapy (QT-019B) for refractory autoimmune hemolytic anemia (ASH 2025) - P1 | "Four patients diagnosed with rAIHA wereadministered QT-019B after standard lymphodepletion conditioning, consistingof fludarabine andcyclophosphamide.ResultsAs of July 31, 2025, four patients have completed the dose-limiting toxicity (DLT) observation, with dosinglevels of 3×10⁵/kg (n=1), 1×10⁶/kg (n=2), and 3×10⁶/kg (n=1). Moreover, the study provides important insightsinto the underlying causes of suboptimal in vivo PK expansion. These findings should be considered intothe development of new protocols, as well as inform the advancement of other allogeneic CAR-T celltherapies."

CAR T-Cell Therapy • IO biomarker • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology • Infectious Disease • HLA-C

Rapid normalization of platelet counts in patients with refractory thrombocytopenia associated with systemic lupus erythematosus (SLE) following treatment with allogeneic dual-target CD19/BCMA CAR T-cell therapy (QT-019B) (ASH 2025) - P1 | "Using a "3+3" dose escalation approach, six patients with refractory SLE-ITP received asingle infusion of QT-019B after lymphodepleting conditioning with fludarabine and cyclophosphamide.ResultsFour patients have completed the dose-limiting toxicity (DLT) observation period (three at a dose of1e6.kg and one at 3e6.kg), while two patients are still undergoing DLT observation at a dose of 3e6.kg.Among the first four patients who completed the DLT observation with follow-up periods of 5, 4, 3, and 3months, we noted robust in vivo expansion of the CAR T-cells in all patients, accompanied by completeelimination of pathogenic autoantibodies. Additionally, we will provide single-cell RNA sequencing data from bothbone marrow and peripheral blood samples of at least one patient.ConclusionsIn conclusion, the allogeneic dual-target anti-CD19/BCMA CAR T-cell therapy (QT-019B) demonstratedencouraging pharmacokinetics, pharmacodynamics, safety, and efficacy in this..."

CAR T-Cell Therapy • Clinical • Anemia • Aplastic Anemia • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura • TINCR

Qihan Biotech Presents New Clinical Data on Allogeneic CAR-T Cell Therapies and Preclinical Data on In Vivo CAR-T at the American Society of Hematology (ASH) Annual Meeting (Businesswire) - "Qihan’s oral presentation highlighted clinical data from 20 patients enrolled in three investigator-initiated trials evaluating QT-019B in multiple autoimmune diseases....SLE-ITP (n=6): 5 complete responses (CR) with normalized platelet counts and 1 partial response (PR); APS-associated ITP (n=5): 4 CR with normalized platelet counts; AIHA (n=3): 2 CR with normalized hemoglobin; SLE (n=2): 1 DORIS remission and 1 SRI-4 response at Month 2....FDA has granted Fast Track Designation to QT-019B for the treatment of Immune Thrombocytopenia occurring in patients with SLE (SLE-ITP). Additional preclinical findings presented at ASH provide the scientific foundation for Qihan’s in vivo CAR-T platform."

Fast track • P1 data • Preclinical • Immune Thrombocytopenic Purpura • Systemic Lupus Erythematosus

Qihan Biotech Announces Multiple Presentations at the 2025 American Society of Hematology (ASH) Annual Meeting (Businesswire)

P1 data • Autoimmune Hemolytic Anemia • Systemic Lupus Erythematosus • Thrombocytopenia

Qihan Biotech Announces FDA Clearance of IND for QT-019B, a Universal Dual-Target CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus (Businesswire) - "The clearance enables the initiation of a Phase 1/2 clinical trial in the United States."

IND • New P1/2 trial • Systemic Lupus Erythematosus