{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T00:30:43Z","timestamp":1794011443817,"version":"4.8.0"},"reference-count":51,"publisher":"American Society of Hematology","issue":"10","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,3,6]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Approximately 30% of patients with acute myeloid leukemia (AML) express CD7 on their myeloblasts. We have previously demonstrated that single-chain variable fragment (scFv)\u2013based \u201cnaturally selected\u201d CD7 chimeric antigen receptor T-cell (NS7CAR-T) therapy shows significant efficacy, with a favorable safety profile in T-cell lymphoid malignancies. Here, we derived dual variable heavy-chain domain of a heavy-chain antibody (dVHH) NS7CAR-Ts that have superior CD7 binding specificity, affinity to their scFv-based counterparts, and improved proliferative capability. In this phase 1 clinical trial, we evaluated the efficacy and safety of nanobody-based dVHH NS7CAR-Ts for patients with CD7+ refractory\/relapsed AML. A cohort of 10 patients received dVHH NS7CAR-Ts across 2 dosage levels of 5\u00a0\u00d7 105\/kg and 1\u00a0\u00d7 106\/kg. Before enrollment, patients had undergone a median of 8 (range, 3-17) prior lines of therapy. Seven patients had prior transplants. After NS7CAR-T infusion, 7 of 10 (70%) patients achieved complete remission (CR). The median observation time was 178 days (range, 28-776). Among 7 patients who achieved CR, 3 who relapsed from prior transplants underwent a second allogeneic hematopoietic stem cell transplant (allo-HSCT). One patient remained leukemia free on day 401, and the other 2 died on day 241 and day 776, respectively, from nonrelapse-related causes. Three CR patients without consolidative (allo-HSCT) relapsed within 90 days. All the nonresponders and relapsed patients had CD7 loss. The treatment was well tolerated, with 80% experiencing mild cytokine release syndrome and none had neurotoxicity. This trial underscores the potential promising treatment of dVHH NS7CAR-Ts in providing clinical benefits with a manageable safety profile to patients with CD7+ AML, warranting further investigation. This trial was registered at www.clinicaltrials.gov as #NCT04938115.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2024024861","type":"journal-article","created":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T15:28:49Z","timestamp":1732030129000},"page":"1022-1033","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":56,"title":["Nanobody-based naturally selected CD7-targeted CAR-T therapy for acute myeloid leukemia"],"prefix":"10.1182","volume":"145","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6331-7369","authenticated-orcid":false,"given":"Peihua","family":"Lu","sequence":"first","affiliation":[{"name":"1Hebei Yanda Lu Daopei Hospital, Langfang, China"},{"name":"2Lu Daopei Institute of Hematology, Beijing, 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