Q1-23: Product Identification

*Product identifiers
Not all identifiers below are applicable to all products. The applicable identifier(s) should be found with the product bag or shipping manifest. Choose the identifier(s) that is most appropriate.

Questions 1-4: Specify the identifiers associated with this cell product (check all that apply)

Report the applicable product identifiers. For commercially available CAR-T products, refer to Table 1. For other products, including non-commercially available CAR-Ts and research products, be consistent in reporting. Unless the documentation specifies “batch number” or “lot number”, use Cell product ID for the first identifier, use Batch number if there is a second identifier, and use Lot number for a third identifier.

*Commercially available CAR-T products
Product specific reporting guides are available for Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Tecartus®, Tecelra®, and Yescarta® on the CIBMTR Portal with additional information and examples of documentation.

Table 1. Reporting Commercial Product Identifiers.

Product name	Applicable ID(s)	Source documentation	Additional information
Abecma®	Cell product ID Lot number	Release for Infusion (RFI)	Report the JOIN ID as Cell product ID
Aucatzyl®	Cell product ID	Release for Infusion (RFI) Certificate	Report the Chain of Identity (CoI) ID as Cell product ID
Breyanzi®	Cell product ID Lot number	Release for Infusion (RFI)	Report the JOIN ID as Cell product ID Report the lot numbers for both the CD4+ and CD8+ components in the same field (separate values by a comma).
Carvykti®	Batch number	QA Certificate or Certificate of Compliance
Kymriah®	Batch number Cell product ID	Certificate of Analysis (COA) or Dose Report	Report the product code(s) as Cell Product ID
Tecartus®	Lot number	Certificate of Analysis (COA)
Tecelra®	Cell product ID Lot number	Certificate of Analysis (COA)	Report the COID (chain of identify) number as Cell product ID
Yescarta®	Lot number	Certificate of Analysis (COA)

Question 5: Date of this product infusion

Report the date this product was infused. If the product was infused over multiple days, report the first date of infusion.

*Co-infusions
If the cellular therapy product is being infused as a co-infusion with HCT and is administered on Day -1, enter the infusion date and override the error using the code “Verified Correct.”

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

Question 6-8: Was the entire volume of product infused?

If the product being infused as a cellular therapy is a portion from a prior HCT (e.g., donor cellular infusion), the portion becomes the “entire” product for the purposes of this form. The intent is to capture if the product being infused was given in its entirety or not. If the entire volume of the product was not infused, select No and specify what happened to the reserved portion.

If multiple bags of a commercially available product are shipped to your center and one or more bags are stored for future infusions, report No and specify what happened to the reserved portion.

Questions 9-12: Specify the route of product infusion

*Route of Infusion for Commercially Available Products
If the cellular therapy product infused is the commercially available products Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Tecartus®, Tecelra®, and Yescarta® report the route of infusion as Intravenous.

Specify the route of product infusion.

• Intravenous refers to an infusion into the veins – examples include infusion via central line or via catheter.
• Intramedullary refers to an infusion into the marrow cavity within a bone, such as directly into the proximal tibia or anterior aspect of the femur.
• Intraperitoneal refers to an infusion within the peritoneal cavity.
• Intra arterial refers to an infusion within an artery or arteries.
• Intramuscular refers to an infusion within a muscle.
• Intrathecal / intra-ventricular refers to an infusion within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles. Intrathecal and intra-ventricular are both terms are related to delivery to the brain / spinal cord.
• Intraorgan refers to an infusion within an organ such as the heart, liver, lungs, etc. If the route or product infusion is Intraorgan, indicate the site. If Other site is selected, specify the other site.
• Locally in the tissue refers to an infusion in a restricted area of the body or in a tumor that cannot be classified as intraorgan, includes subcutaneous.

If the route of infusion is not one of the above options, select Other route of infusion and specify the other infusion route.

!Total number of cells
Report the total number of cells (not cells per kilogram) contained in the product administered.

These questions collect the total number of cells that were infused the product administered. All the cell types reported on the Cellular Therapy Product (4003) form should be included here. Only report the cells that are applicable to this infusion. Note, CD3 is present on all T-cells whether they are CD4+ or CD8+ T- cells.

*Reporting Cell Counts for Commercially Available Products
Product specific reporting guides for reporting cells administered are available for Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti®, and Kymriah® on the CIBMTR Portal. Reference the reporting guide when reporting cell counts.

Questions 13-14: Total number of cells administered

*Total Number of Cells Administered and Commercially Available Products
Total number of cells administered will be disabled for the commercially available products Abecma®, Amtagvi®, Aucatzyl®, Carvykti®, Kymriah®, Tecelra®, Tecartus®, or Yescarta®.

Report the total cell count contained in the product administered. If the type of cells is not specified, report the total number of cells present at time of the infusion. If multiple bags were infused together, report the sum of each bag.

*Cells Administered for Tecartus® and Yescarta®
Specify the cell type(s) administered will be disabled for the commercially available products Tecartus® or Yescarta®.

*Reporting Cell Types for Commercially Available Products
Product specific reporting guides for reporting cells administered are available for Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti®, and Kymriah® on the CIBMTR Portal. Reference the reporting guide when reporting cell counts.

*Cell Type for Commercially Available Products
For commercially available products Abecma®, Amtagvi®, Aucatzyl®, Carvykti®, Kymriah®, and Tecelra® report the cell type as Lymphocytes (unselected).

Questions 15-23: Specify the cell type(s) administered (check all that apply)

Select all applicable cell type(s) of the infused cellular product being reported on this form and report the total number of cells infused. For non-commercial products, this information can be found on the infusion record.

All cell types selected here must also be reported on the corresponding Cellular Therapy Product (4003) 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.

See the F4003 manual for cell type descriptions *Lymphocytes (unselected)

• CD4+ lymphocytes
• CD8+ lymphocytes
• Regulatory T-cells (TREG)
• Mesenchymal stromal stem cells (MSCs)
• Unspecified mononuclear cells
  

If the cell type infused is not listed above infused, select Other cell type and specify the other cell type, and report the total number of cells administered in the infusion.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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