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GUIDANCE DOCUMENT

Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products January 2024

Final
Docket Number:
FDA-2021-D-0404
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

Chimeric antigen receptor (CAR) T cell products are human gene therapy  products in which the T cell specificity is genetically modified to enable recognition of a desired target antigen for therapeutic purposes.  This guidance is intended to assist sponsors, including industry and academic sponsors, developing CAR T cell products.  In this guidance, we, FDA, provide CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.  Recommendations specific to autologous or allogeneic CAR T cell products are noted in this guidance.  This guidance also provides recommendations for analytical comparability studies for CAR T cell products.  While this guidance specifically focuses on CAR T cell products, much of the information and recommendations provided will also be applicable to other genetically modified lymphocyte products, such as CAR Natural Killer (NK) cells or T cell receptor (TCR) modified T cells.  These related product types can be highly specialized, and in many cases, considerations beyond those recommended in this guidance would depend on the specific product and manufacturing process.  To discuss considerations specific to these related products, we recommend sponsors communicate with the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER) before submitting an Investigational New Drug Application (IND) (e.g., by requesting a pre-IND meeting (Ref. 1)).

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual public webinar on Thursday, March 7 at 1:00 p.m. to highlight key considerations in the final guidance.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0404.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
 
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