4000: Cellular Therapy Essential Data Pre-Infusion

This form must be completed for all recipients of cellular therapy (non-HCT) with or without a prior HCT. CAR-T cells, tumor-infiltrating lymphocytes, and cytotoxic T cells are common cellular therapies that should be reported using this form. Regenerative medicine indications can be reported using this form with the exception of genetic modified hematopoietic stem cells to treat malignant hematologic or other non- malignant indications. These infusions are considered transplants and should be reported using the Pre- Transplant Essential Data (Pre-TED) Form 2400.
For recipients of hematopoietic cellular transplants (HCT), complete the Pre-TED (2400) and Disease Classification (2402) forms.
Donor Lymphocyte Infusions (DLI) are no longer captured on the Pre-CTED (4000) form. An infusion can be classified as a DLI when:

• It’s an infusion of a lymphocyte-only product
• The infusion must be post-Allogeneic HCT and will most likely be from the same HCT donor
• The product cannot be genetically modified

Donor Lymphocyte Infusion (2199) form should be completed.
This form reflects pre-infusion essential data for a course of cellular therapy. All cellular therapies (non- HCT) are collected on this form, including indications that reflect donor cellular infusions (DCI) done post- transplant, now referred to as “post-HCT cellular therapy”. A course of cellular therapy includes all infusions given per protocol, or when multiple infusions are given for the same indication using the same product/ donor (e.g., post-HCT cellular therapy (DCI)). The Pre-CTED Form is due within 30 days after infusion.

*Multiple Infusions
Multiple infusions of commercially available products require a separate Pre-Cellular Therapy Essential Data (4000) form for each infusion.
The use of cellular therapy is expanding. Treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g. cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR T-cells).

*Commercially available products
Product specific reporting guides are available for Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Tecartus®, Tecelra®, and Yescarta® on the CIBMTR Portal. The reporting guides contain product specific reporting instructions for completing CIBMTR cellular therapy forms.

!Consent Status and Baseline Forms
There has been a change to the functionality of submitting the Pre-Transplant Essential Data (2400), Pre-Transplant Essential Data Disease Classification (2402), and Pre-Cellular Therapy Essential Data (4000) forms. If a consent status has not yet been reported for a recipient, the edit form icon will appear disabled (see Figure 1 below). When the user hovers over the icon, it will display that consent has not yet been reported for that recipient (see Figure 2 below). The user should go to the Consent Tool (see Navigation to the Consent Tool) and document the recipient’s consent status in order to enable the edit icon and allow for completion of the form.

Figure 1. Disabled Edit Form Icon

Figure 2. Hovered Text, Consent Not Yet Reported

Links to sections of form:
Q1-25: Recipient Data
Q26-45: Cellular Therapy and HCT History
Q46-65: Product Identification
Q66-85: Indication for Cellular Therapy
Q86-91: Holding / Bridging Therapy Prior to Infusion
Q92-98: Lymphodepleting Therapy Prior to Cellular Therapy
Q99-102: Hematologic Findings Prior to Lymphodepleting Therapy
Q103-106: Functional Status
Q107-119: Comorbid Conditions

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.

To reference the historical Manual Change History for this form, review the retired manual section on the Retired Forms Manual webpage.

Section Updates:

Date of Change	Manual Section	Add/Remove/Modify	Description
1/23/2026	4000: Cellular Therapy Essential Data Pre-Infusion	Add	Version 11 of the Cellular Therapy Essential Data Pre-Infusion section of the Forms Instructions Manual released. Version 11 corresponds to revision 11 of the Form 4000.

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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.