Q2-10: Cell Product Source

Question 2: Date of cell product collection

Report the date of cell product collection.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 3-4: What is the tissue source of the cellular product? (check all that apply)

*Tissue Source for Commercially Available Products
Select Peripheral blood if the product is the commercially available product Abecma®, Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Tecartus®, Tecelra®, or Yescarta®.

*Tissue Source for Commercially Available Products
Select Tumor if the product is the commercially available product Amtagvi®.

The tissue source for non-mobilized peripheral blood, peripheral blood apheresis, and MNCs should be reported as peripheral blood.

Questions 5-6: What is the cell type? (check all that apply)

*Cell Type for Commercially Available Products
Select Lymphocytes (unselected) if the product is the commercially available product Abecma®, Amtagvi®, Aucatzyl®, Carvykt®, Kymriah®, Tecelra®, Tecartus®, or Yescarta®.

*Cell Type for Commercially Available Products
Select CD4+ lymphocytes and CD8+ lymphocytes if the product is the commercially available product Breyanzi®

Select all applicable cell type(s) of the infused cellular product being reported on this form. All cell types selected here must also be reported on the corresponding Cellular Therapy Product (4006) form.

!CAR-T cells
Please note that “CAR-T” is not an option. CAR-T cells are manufactured from lymphocytes. Select the appropriate option based on the product.

• Lymphocytes (unselected): Unselected means a specific lymphocyte sub-population (e.g., CD4+) was not targeted. This includes all types of lymphocytes, those that have not been selected via flow cytometry or other method. Note, CD3 is present on all T-cells whether they are CD4+ or CD8+ T- cells. Select this option if only CD3 is noted in the report.

• CD4+ lymphocytes: The lab report may display this value as CD3+CD4+. These cells are also known as T-helper cells.

• CD8+ lymphocytes: The lab report may display this value as CD3+CD8+. These cells are also known as cytotoxic T-cells which can destroy virus-infected cells, tumor cells, tissue grafts, etc.

• Regulatory T-cells (TREG): TREG cells express the biomarkers CD4, FOXP3, and CD25.

• Mesenchymal stromal stem cells (MSCs): MSCs are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells).

• Unspecified mononuclear cells: A mononuclear cell is defined as any blood cell with a round nucleus (i.e., a lymphocyte, a monocyte, or a macrophage). These blood cells are a critical component of the immune system’s ability to fight infection and adapt to intruders.

If the cell type infused is not listed above infused, select Other cell type and specify the other cell type.

Questions 7-10: Where was the cellular therapy product manufactured / processed?

!Manufacture Questions for Commercially Available Products
Manufacture questions will be disabled for commercially available and pre-commercial products. The questions will only enable if the product name was reported as Other product or No product name on the Pre-CTED (4000) form.

Pharmaceutical or biotech company: Select the company name. If the company name is not listed, select Other pharmaceutical company and specify the name and location.

Cell processing laboratory off site: A laboratory that is not a pharmaceutical / biotech company and not located within the institution. Report the name and location of the laboratory.

Cell processing laboratory at the same center as the product is being infused: A laboratory that is not a pharmaceutical / biotech company and is located within the institution. Select this option if the product is from an NMDP donor used for a prior HCT.

If the product was manufactured by another site not listed above, select Other site, specify the other site, and report the name and location where the cell therapy product was manufactured / processed.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.