APA
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Derigs, P., Schubert, M.-L., Dreger, P., Schmitt, A., Yousefian, S., Haas, S., … Schmitt, M. (2024). Third-generation anti-CD19 CAR T cells for relapsed/refractory chronic lymphocytic leukemia: a phase 1/2 study. Leukemia.
Chicago/Turabian
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Derigs, P., Maria-Luisa Schubert, Peter Dreger, Anita Schmitt, S. Yousefian, Simon Haas, Caroline Röthemeier, et al. “Third-Generation Anti-CD19 CAR T Cells for Relapsed/Refractory Chronic Lymphocytic Leukemia: a Phase 1/2 Study.” Leukemia (2024).
MLA
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Derigs, P., et al. “Third-Generation Anti-CD19 CAR T Cells for Relapsed/Refractory Chronic Lymphocytic Leukemia: a Phase 1/2 Study.” Leukemia, 2024.
BibTeX Click to copy
@article{p2024a,
title = {Third-generation anti-CD19 CAR T cells for relapsed/refractory chronic lymphocytic leukemia: a phase 1/2 study},
year = {2024},
journal = {Leukemia},
author = {Derigs, P. and Schubert, Maria-Luisa and Dreger, Peter and Schmitt, Anita and Yousefian, S. and Haas, Simon and Röthemeier, Caroline and Neuber, Brigitte and Hückelhoven-Krauss, Angela and Brüggemann, Monika and Bernhard, Helga and Kobbe, G. and Lindemann, Albrecht and Rummel, Mathias and Michels, Birgit and Korell, Felix and Ho, Anthony D and Müller-Tidow, Carsten and Schmitt, Michael}
}
Third-generation chimeric antigen receptor T cells (CARTs) for relapsed or refractory (r/r) chronic lymphocytic leukemia (CLL) may improve efficacy compared to second-generation CARTs due to their enhanced CAR design. We performed the first phase 1/2 investigator-initiated trial evaluating escalating doses of third-generation CARTs (HD-CAR-1) targeting CD19 in patients with r/r CLL and B-cell lymphoma. CLL eligibility criteria were failure to two therapy lines including at least one pathway inhibitor and/or allogeneic hematopoietic cell transplantation. Nine heavily pretreated patients received HD-CAR-1 at dose levels ranging from 1 × 106 to 200 × 106 CART/m2. In-house HD-CAR-1 manufacturing was successful for all patients. While neurotoxicity was absent, one case of grade 3 cytokine release syndrome was observed. By day 90, six patients (67%) attained a CR, five of these (83%) with undetectable MRD. With a median follow-up of 27 months, 2-year PFS and OS were 30% and 69%, respectively. HD-CAR-1 products of responders contained significantly more CD4 + T cells compared to non-responders. In non-responders, a strong enrichment of effector memory-like CD8 + T cells with high expression of CD39 and/or CD197 was observed. HD-CAR-1 demonstrated encouraging efficacy and exceptionally low treatment-specific toxicity, presenting new treatment options for patients with r/r CLL. Trial registration: #NCT03676504.