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