4003: Cellular Therapy Product

This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT DCI infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006) form. For recipients of Donor Lymphocyte Infusions (DLI), complete the Donor Lymphocyte Infusion (2199) form.

The Cellular Therapy Product (4003) form is designed to capture product specific information for all products given to a recipient as part of a course of cellular therapy. A series of collections from the same donor that uses the same collection method, even if the collections are performed on different days, should be considered a single cellular therapy product if only one set of manufacturing steps are applied to the collected material.

If more than one type of cellular therapy product is infused as part of a single course of cellular therapy, each product type must be analyzed and reported on a separate Cellular Therapy Product (4003) form. A product from the same donor undergoing different manufacturing steps or manipulations is considered different products and require multiple Cellular Therapy Product (4003) forms if each product is infused separately.

However, if the cells underwent different manufacturing steps or manipulations and at the end of the manufacturing process were combined for a single infusion or administration, it will be considered a single product and it will require a single Cellular Therapy Product (4003) form.

For more information see Appendix D–How to Distinguish Infusion Types and Appendix E–Definition of a Product.

Links to sections of form:
Q1-2: Cellular Therapy Product Identification
Q3-12: Cell Product Source
Q13-15: Collection Procedure
Q16-37: Cell Product Manipulation
Q38-46: Cell Product Analysis
Q47: Product Infusion

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals.

Date	Manual Section	Add/Remove/Modify	Description
9/23/2022	4003: Cellular Therapy Product	Modify	Updated for new DLI reporting process: This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT DCI / DLI” infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006) form. For recipients of Donor Lymphocyte Infusions (DLI), complete the Donor Lymphocyte Infusion (2199) form.
9/23/2022	4003: Cellular Therapy Product	Remove	Removed blue note box below question 1: If your center considers this to be a Donor Lymphocyte Infusions (DLI), as reported on the Pre-CTED (4000) form, product name will not be auto-populated. Select Other product for the product name.
9/23/2022	4003: Cellular Therapy Product	Add	Added commercially available CAR-T product CarvyktiTM to the blue note box below question 5: For commercially available products Kymriah®, Yescarta®, TecarutsTM, BreyanziTM, and Abecma®, and CarvyktiTM, report the tissue source as Peripheral blood.
9/23/2022	4003: Cellular Therapy Product	Add	Added commercially available CAR-T product CarvyktiTMto the blue note box below question 7: For commercially available products Kymriah®, Yescarta®, TecarutsTM, BreyanziTM, and Abecma®, and CarvyktiTM, report the cell type as Lymphocytes (unselected).
9/23/2022	4003: Cellular Therapy Product	Modify	Removed the reference to DLI: If the product (e.g., DLI/ DCI) being infused as a cellular therapy is a portion from a prior HCT, the portion becomes the “entire” product for the purposes of this form. The product can then be further divided.
9/23/2022	4003: Cellular Therapy Product	Remove	Removed Example 3: The recipient receives two DLI infusions and the notes do not specify additional infusions are to be given. Report ‘2’ and submit the form. The recipient then goes on to receive another DLI infusion for the same indication using the same donor / product. The number reported here should be updated to trigger another Cellular Therapy Infusion (4006) form.
4/11/2022	4003: Cellular Therapy Product	Add	Instruction added for the preferred timepoint of viability when the product was cryopreserved: If the product was cryopreserved, viability post-thaw should be reported.
1/28/2022	4003: Cellular Therapy Product	Modify	Version 5 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 5 corresponds to revision 5 of the Form 4003.

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