CD19 CAR-T Cell Monitoring by Flow Cytometry Programme (Pilot - Not Accredited)

Programme objective: To assess a laboratory’s ability to detect CD19 CAR-T cells using flow cytometry.

Clinical/scientific background: Chimeric Antigen Receptor (CAR) T-cell therapy is a form of immunotherapy used to treat various forms of haematological malignancies. A patient’s T cells are removed by leukapheresis and engineered in order to express a CAR. The CAR-T cells are manufactured so that they specifically target and destroy cells expressing the antigen they were manufactured for. The CAR-T cells are then cultured before they are infused back into the patient. Currently, there are licensed CAR-T cells available to treat haematological malignancies with CD19 and B Cell Maturation Antigen (BCMA) as the targets. Monitoring CAR T-cell populations in routine use is helpful to evaluate the success of the therapy and the status of the applied CAR-T cells. Such patient monitoring helps to estimate the systemic immune response and indicate the risk of immediate adverse effects or long-term complications¹.

Suitability: Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the detection and enumeration of CAR-T cells in a sample.

Samples are suitable for use with whole blood lysis techniques and sequential gating strategies. Laboratories are requested to report the percentage of CAR-T cells in the sample.

All EQA programme communications, data entry, and reports will be conducted exclusively in the English language. Participants must ensure proficiency in English to fully engage in the programme.

The programme welcomes participation from diverse sectors including:

Clinical Healthcare Laboratories
Academic and Research Institutions
In Vitro Diagnostics (IVD) Manufacturers
Pharmaceutical companies

Participation level is currently limited to 30 participants; however, this may be expanded as time goes on.

Sample type/distribution: The programme uses stabilised peripheral blood containing CAR-T cells obtained from either consenting patients following CAR-T cell therapy or off-the-shelf CAR-T cells. The programme issues one sample per trial with one trial scheduled for issue per year although this may be increased.

Trial duration: Trials for this programme are live/open for a week. Due to the nature of the sample, participants will be required to test the sample within a week of receipt. Sample delivery will be by courier only.

Subcontracted areas: No activities in relation to this EQA programme are subcontracted. CAR-T cells used in manufacturing the samples may be obtained from a commercial company.

Updates to the programme for current or upcoming year: N/A

To register for this programme, please click here.

References

Blache U, Weiss R, Boldt A, Kapinsky M, Blaudszun AR, Quaiser A, Pohl A, Miloud T, Burgaud M, Vucinic V, Platzbecker U, Sack U, Fricke S and Koehl U (2021) Advanced Flow Cytometry Assays for Immune Monitoring of CAR-T Cell Applications. Front. Immunol. 12:658314. doi: 10.3389/fimmu.2021.658314