Qihan’s dual-target CD19/BCMA CAR-T achieves FDA’s “triple crown” for autoimmune diseases

Edited by Robert McTiernan··3 min read

China-based Hangzhou Qihan Biotech Co., Ltd. announced that QT-019B, its allogeneic dual-target chimeric antigen receptor T (CAR-T) cell therapy, has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Breakthrough Therapy Designation (BTD) from the US FDA. The two designations, awarded simultaneously in June 2026, follow a Fast Track Designation (FTD) granted in November 2025, giving QT-019B all three of the FDA’s principal expedited development pathways — a combination the company describes as an FDA “triple crown”. QT-019B targets CD19 and BCMA simultaneously and is engineered using Qihan’s multiplexable genome editing platform to incorporate T cell receptor (TCR) knockout and hypoimmunity modifications.

The clinical data supporting the designations were presented at the American Society of Hematology (ASH) Annual Meeting in December 2025 and published in Blood as an ASH 2025 abstract. Across 20 patients with refractory autoimmune diseases enrolled in investigator-initiated Phase I trials, QT-019B demonstrated a 100% overall response rate in systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP), with five complete responses and one partial response among six evaluable patients. In antiphospholipid syndrome-associated ITP (APS-ITP), four of five patients achieved complete responses. No events exceeding Grade 1 cytokine release syndrome (CRS) were reported across all 20 treated patients, and no graft-versus-host disease (GvHD) was observed — findings consistent with the therapy’s TCR knockout design. The June 2026 regulatory announcement itself contained no new clinical data; the ASH 2025 disclosure represents the most detailed public dataset supporting all three designations.

RMAT designation, established under the 21st Century Cures Act of 2016, is specific to regenerative medicine products including cell and gene therapies, and provides rolling review eligibility, early and frequent FDA interactions, and potential pathways to Accelerated Approval and Priority Review. BTD offers intensive FDA guidance beginning as early as Phase I, direct involvement from senior FDA leadership, and eligibility for rolling and Priority Review. Together, the two designations materially accelerate the agency’s collaborative engagement with Qihan through the development process.

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Qihan is focused on off-the-shelf cell therapies developed through multiplex genome editing. QT-019B is derived from healthy donor leukapheresis products and engineered to stably express two distinct CARs directed against CD19 and BCMA, enabling concurrent recognition of cells expressing either antigen. The TCR is knocked out to reduce GvHD risk. Multiplexable gene editing is additionally used to confer hypoimmunity — reducing recognition and elimination of the CAR-T cells by the patient’s own NK and T cells — which is designed to extend in vivo persistence compared with conventional allogeneic constructs.

The indication pursued in the ASH 2025 dataset is refractory autoimmune disease rather than the hematologic malignancies for which CD19 and BCMA are most established as targets. SLE-ITP and APS-ITP represent conditions where B-cell and plasma-cell depletion via dual CD19/BCMA targeting may address the underlying autoantibody-producing cell populations. The 100% overall response rate in SLE-ITP and 80% complete response rate in APS-ITP across a small but heavily pretreated population provided the preliminary clinical evidence threshold required for both BTD and RMAT.

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