Drugs / QT-019B
last change Jun 2026 re-read 3 minutes ago

QT-019B

Cell therapy targets CD19

Developed for
systemic lupus erythematosus
Investigated by
Hangzhou Qihan Biotech Co., Ltd.

Trials 1

2026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07444307 Dec 2025 → Dec 2028 expected systemic lupus erythematosus Hangzhou Qihan Biotech Co., Ltd. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-06-11 Hangzhou Qihan Biotech Co., Ltd. Regulatory Qihan Biotech's QT-019B Receives FDA RMAT and BTD qihanbio.com ↗
2025-12-09 Hangzhou Qihan Biotech Co., Ltd. Results 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 qihanbio.com ↗
Qihan’s oral presentation highlighted clinical data from 20 patients enrolled in three investigator-initiated trials evaluating QT-019B in multiple autoimmune diseases.
2025-11-03 Hangzhou Qihan Biotech Co., Ltd. Results Qihan Biotech Announces Multiple Presentations at the 2025 American Society of Hematology (ASH) Annual Meeting qihanbio.com ↗
Robust pharmacokinetic, pharmacodynamic, safety, and efficacy data from 17 patients with autoimmune diseases (SLE, AIHA, and MS) demonstrate consistent clinical benefit.
2025-08-13 Hangzhou Qihan Biotech Co., Ltd. Regulatory Qihan Biotech Announces FDA Clearance of IND for QT-019B, a Universal Dual-Target CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus qihanbio.com ↗
Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for QT-019B.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as QT-019B ClinicalTrials.gov intervention name — accepted as the source's own label NCT07444307 ↗
Modality Cell therapy “Universal Allogeneic CAR-T Cells” NCT07444307 ↗
Target CD19 “Targeting CD19 and BCMA” NCT07444307 ↗