Q5-9: Disease Relapse or Progression

!Antigen escape
These question will enable only if the commercially available product Kymriah®, Yecarta®, Tecartus^TM, or Breyanzi^TM is selected in question 1.
There is no current testing method for the BCMA CAR-T products (Abecma®, Carvykti^TM).

Question 5: Was there evidence of antigen escape?

*Antigen escape occurs in the context of relapse.

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 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 in question 6.

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.

Report Yes if there was evidence of antigen escape.

If testing showed no evidence of antigen escape in the current reporting period, report No. If no testing was performed in the current reporting period, report Not tested.

Question 6-7: 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 8: Was documentation submitted to CIBMTR?

Indicate whether documentation of the antigen escape 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 9: Date of antigen escape

Report the date (YYYY – MM- DD) when testing first showed evidence of antigen escape. If the exact date is not known, use the process described in the General Instructions, General Guidelines for Completing Forms.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
5	1/15/24	Modify	Added the text in red: 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 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 in question 6. 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.	Clarifying what type of test will show antigen escape
5	12/12/23	Modify	Updated red warning box above question five: These question will enable only if the commercially available product Kymriah®, Yecarta®, TecartusTM, or BreyanziTM is selected in question 1. There is no current testing method for the BCMA CAR-T products (Abecma®, CarvyktiTM).	Clarifying context of question for BCMA products.
5	12/12/23	Modify	Reformatted and created an example: 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 their leukemia/lymphoma cells no longer express CD19.	Clarifying the manual text and example.
5	8/22/23	Modify	Update: Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This is occurs when disease relapses and the tumor develops partial or complete loss of the tumor antigen. An example is a recipient with acute lymphoblastic leukemia (ALL) that expresses the CD19 antigen prior to cellular therapy infusion.	Clarifying that antigen escape occurs in the context of relapse
5	8/22/23	Add	New blue note box added under question 5: Antigen escape occurs in the context of relapse.	Clarifying that antigen escape occurs in the context of relapse

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