Results
ELN, febrile neutropenia, toxicity, toxicities, SD, infection, pyrexia
DISEASE PROGRESSION, FEBRILE NEUTROPENIA, ADVERSE EVENTS, DISEASE, INFECTION, REMISSION, ADVERSE EVENT, EVENTS
The TCB-202-001 trial opened in November 2018 and was terminated prematurely in March 2020 due to the COVID-19 pandemic. Ten patients were recruited of which 2 patients (5004, 5005) failed screening and 2 could not be followed up due to early trial closure: of these, 1 (5010) did not have day 28 marrow evaluation, whilst 1 patient (5011) did not receive a planned infusion. A patient summary is depicted in TCB-202-001 Patient SummaryAbbreviations: ALLO-HCT = allogeneic hematopoietic cell transplantation; CR = complete response; FLA/DAU = fludarabine, cytarabine, daunorubicin; FLA/IDA = fludarabine, cytarabine, idarubicin; HIDAC = high-dose cytarabine; IDAC = intermediate-dose cytarabine; LD-AraC = low-dose cytarabine; MLFS = morphologic leukemia-free state; NR = no response; SD = stable disease.Previous therapy = each bullet point corresponds to 1 chemotherapy treatment regimen or stem cell transplant: “3+7”: standard dose cytarabine with daunorubicin or idarubicin.Responses were evaluated according to ELN 2017 criteria.Survival and disease status from infusion in evaluable patients.Seven patients (5002; 5003; 5006; 5007; 5008; 5009, and 5010) received donor-derived T cell products all with >5% baseline blasts in bone marrow. Five survived to day 14 post-treatment. Patient 5003 died from infection on Day 14, categorized by the SRC as unlikely to be drug-related, while patient 5008 discontinued on day 14 due to disease progression. Four patients (5002; 5005; 5007, and 5009) had 28-day bone marrow evaluation, when 1 (5007) had complete remission (CR), 1 (5006) was classified morphologic leukemia-free state (MLFS), 1 (5002) had stable disease (SD) and 1 (5009) had no evidence of response. Weekly toxicity evaluations were performed through day 28 to determine dose-limiting toxicities.Treatment emergent adverse events classified as serious or treatment-related are summarized in TCB-202-001 Summary of Treatment Emergent AEsTEAE = treatment emergent adverse event.Two patients were reported to have related TEAE. These events were pyrexia of CTCAE grade 1 in 1 patient and increased C-reactive protein of CTCAE grade 2 in 1 patient. These events were not classified as serious adverse events.In total 4 patients experienced a SAE. These were febrile neutropenia of CTCAE grade 3 in 1 patient, 