期刊
JOURNAL OF CLINICAL ONCOLOGY
卷 39, 期 30, 页码 3340-+出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1200/JCO.21.00389
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资金
- National Key R&D Program of China [2019YFA0110200]
- Tianjin Science Funds for Distinguished Young Scholars [17JCJQJC45800]
- CAMS Innovation Fund for Medical Sciences (CIFMS) [2016-I2M-1-003]
- Non-Profit Central Research Institute Fund of Chinese Academy of Medical Sciences [2018PT32034, 2019-RC-HL-013]
Donor-derived anti-CD7 CAR T cells showed efficient expansion and high complete remission rate in patients with r/r T-ALL, with manageable adverse events.
PURPOSE Patients with relapsed or refractory T-cell acute lymphoblastic leukemia (r/r T-ALL) have few options and poor prognosis. The aim was to assess donor-derived anti-CD7 chimeric antigen receptor (CAR) T-cell safety and efficacy in patients with r/r T-ALL. METHODS In this single-center, phase I trial, we administered anti-CD7 CAR T cells, manufactured from either previous stem-cell transplantation donors or new donors, to patients with r/r T-ALL, in single infusions at doses of 5 x 10(6) or 1 x 10(6) (+/- 30%) cells per kilogram of body weight. The primary end point was safety with efficacy secondary. RESULTS Twenty participants received infusions. Adverse events including cytokine release syndrome grade 1-2 occurred in 90% (n = 18) and grade 3-4 in 10% (n = 2), cytopenia grade 3-4 in 100% (n = 20), neurotoxicity grade 1-2 in 15% (n = 3), graft-versus-host disease grade 1-2 in 60% (n = 12), and viral activation grade 1-2 in 20% (n = 4). All adverse events were reversible, except in one patient who died through pulmonary hemorrhage related to fungal pneumonia, which occurred at 5.5 months, postinfusion. Ninety percent (n = 18) achieved complete remission with seven patients proceeding to stem-cell transplantation. At a median follow-up of 6.3 months (range, 4.0-9.2), 15 remained in remission. CAR T cells were still detectable in five of five patients assessed in month 6, postinfusion. Although patients' CD7-positive normal T cells were depleted, CD7-negative T cells expanded and likely alleviated treatment-related T-cell immunodeficiency. CONCLUSION Among 20 patients with r/r T-ALL enrolled in this trial, donor-derived CD7 CAR T cells exhibited efficient expansion and achieved a high complete remission rate with manageable safety profile. A multicenter, phase II trial of donor-derived CD7 CAR T cells is in progress (NCT04689659). (C) 2021 by American Society of Clinical Oncology
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