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. 2023 Jul 22;16:79. doi: 10.1186/s13045-023-01470-0

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© The Author(s) 2023

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

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Fig. 1 — HD-CAR-1 study profile. Fifteen patients with relapsed and/or refractory (r/r) acute lymphoblastic leukemia (ALL) after at least two prior therapy lines were screened and enrolled into HD-CAR-1. For all patients, leukapheresis and manufacturing of CARTs were feasible. Two patients did not receive the HD-CAR-1 CART product due to progressive disease (PD). Thirteen patients were treated with CARTs, with three patients receiving 1 × 10⁶ (dose level (DL) 1), three patients 5 × 10⁶ (DL2), four patients 20 × 10⁶ (DL3) and three patients 5 × 10⁷ (DL4) CARTs/m². Ten patients reached end of study (EOS) on day 90 after CART administration. Three patients died due to progressive disease (n = 2) or due to septic organ failure (n = 1) prior to EOS