SAN DIEGO, CA — May 5, 2026 — Leads & Copy — Fate Therapeutics, Inc. (NASDAQ: FATE) announced that the U.S. Food and Drug Administration (FDA) has selected FT819 for participation in the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program for treatment of moderate to severe systemic lupus erythematosus (SLE).
The FDA CDRP Program is designed for investigational therapies intended to diagnose, treat, or prevent serious diseases with unmet medical need and is limited to sponsors that have received Regenerative Medicine Advanced Therapy (RMAT) or Breakthrough Therapy Designation (BTD). The program is a highly selective initiative, with no more than nine proposals accepted annually across the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
Participation in the CDRP Program is intended to accelerate product development by enabling enhanced, product-specific FDA engagement on CMC related matters. The program provides increased communication with the FDA, including additional CMC-focused Type B meetings to help clarify development strategies, address key questions, and support manufacturing readiness, ultimately helping to ensure that the CMC readiness for marketing keeps pace with expected faster clinical timelines, so that product approvals are not held up by CMC bottlenecks.
“The selection of FT819 into the FDA’s CDRP Program is a powerful validation of the science we have built at Fate Therapeutics and a meaningful step forward in our path to commercialization,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics.
According to the announcement, the selection into the CDRP program, combined with RMAT designation, is intended to accelerate manufacturing readiness as the company embarks on its Phase 2 potentially registrational clinical trial in SLE. FT819 is designed to be administered on an outpatient basis with same-day discharge, and the company’s off-the-shelf approach enables on-demand availability across community hospitals and in outpatient settings, making transformative CAR T-cell therapy accessible to patients who have historically faced significant barriers to treatment.
FT819 is an off-the-shelf anti-CD19 chimeric antigen receptor (CAR) T-cell therapy candidate currently under investigation for patients with various B-cell related autoimmune disorders. A precisely engineered clonal master induced pluripotent stem cell (iPSC) line serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies, analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies. Broad patient accessibility is enabled under the FT819 Phase 1 autoimmune basket clinical protocol, especially in underserved regions, with on-demand availability of drug product and outpatient treatment with same-day discharge.
FT819 previously received RMAT designation from the FDA for the treatment of moderate-to-severe SLE. The RMAT designation was granted based on preliminary clinical evidence demonstrating the potential of FT819 to address significant unmet need in patients with SLE. The RMAT designation provides the Company with benefits including FDA guidance on efficient development, alignment on CMC readiness, and the potential for accelerated approval.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA.
Source: Fate Therapeutics, Inc.
