Automated GMP process makes CCR5-edited CAR-T cells on the CliniMACS Prodigy

Primary source Human Gene Therapy (SAGE): Automated Production of Gene-Edited CAR-T Cells for People Living with HIV 8 Oct 2026

3.9 × 10^9

A team at the University Medical Centre in Hamburg, Germany, reports an integrated, GMP-compliant process (good manufacturing practice) for making gene-edited CAR-T cells on the CliniMACS Prodigy, an automated cell-processing platform. The paper was published online on 8 October 2026 in Human Gene Therapy. This piece rests on the abstract only: the full text could not be opened, so methods and run-by-run data are not covered.

What was built

The process combines two steps in one workflow. Lentiviral vectors deliver a CD19-directed chimeric antigen receptor (CAR). In the same process, mRNA electroporation introduces the authors’ transcription activator-like effector nuclease, CCR5-Uco-hetTALEN, which knocks out CCR5, a coreceptor that HIV uses. The authors say T-cell products from people living with HIV need special manufacturing conditions to suppress HIV replication, and they chose CD19-CAR-T cells for HIV-positive cancer patients as the example case.

What the runs produced

• Three manufacturing runs were performed on a clinical scale.
• Up to 3.9 × 10^9 viable T cells were generated in a run.
• Between 37% and 55% of the T cells in the final product expressed functional CD19-CARs.
• The overall CCR5 editing rate, the share of cells in which CCR5 was edited, ranged from 42% to 54%.
• The third, large-scale run was performed in the presence of the antiretroviral drug saquinavir, to suppress potential viral replication during manufacturing of cells from HIV-positive patients.

The abstract does not say whether the cells used were from HIV-positive donors, and it gives no per-run breakdown, vector details or release-testing results.