Q4-8: Disease Relapse or Progression

!Antigen escape
These questions will only enable for the CAR-T products that target CD19+ cells (Aucatzyl®, Breyanzi®, Carteyva®, Kymriah®, Tecartus®, Yescarta®, rapcabtagene autoleucel or zamtocabtagene autoleucel).
There is no current testing method for the BCMA CAR-T products (Abecma®, Carvykti®).

Question 4: Was there evidence of antigen escape?

*Antigen escape
Antigen escape occurs in the context of relapse. This question does not apply if there is no evidence of relapse or progression.

*Combined Follow-Up
In scenarios where an HCT was given after a cellular therapy and this form is now being completed based on the subsequent HCT date, these questions do not apply and are disabled.

Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This occurs when the disease relapses and the tumor develops partial or complete loss of the tumor antigen. This may be determined by testing (e.g. T-cell subset profile) on the blood and/or bone marrow showing absence of the tumor antigen targeted by the cellular therapy they received. Common testing methods are listed below.

If the recipient relapsed or progressed, by any method of assessment, indicate Yes or No if there was evidence of antigen escape.

Not applicable should be reported when there is no evidence of relapse / progression.

If no testing was performed in the current reporting period, report Not tested.

Example 1: A recipient has a CD19 expressing disease prior to the cell therapy infusion, such as acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). The recipient is given a CD19-directed CAR T-cell therapy, achieves a CR then relapses. At the time of relapse, the T-cell subset profile shows the absence of CD19+ B-cells. This means the leukemia/lymphoma cells no longer express CD19. In this example, report Yes because there was antigen escape.

Questions 5-6: Method of detection of antigen escape (check all that apply)

Methods of detecting antigen escape include Flow cytometry, Immunohistochemistry (IHC) or Other method. Select the method(s) used to detect antigen escape. If Other method is selected, specify the method.

Question 7: Was documentation submitted to CIBMTR? (e.g., pathology; CIBMTR strongly recommends attaching documentation)

Indicate whether documentation of the antigen escape testing was submitted to CIBMTR (e.g., flow cytometry, immunohistochemistry report).

For further instructions on how to attach documents in FormsNet3^SM, refer to the Formsnet3 Training Guide.

Question 8: Date of antigen escape

Report the date when testing first showed evidence of antigen escape.

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

Section Updates:

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