Dilanubicel

also known as NLA101

Developed for: myelodysplastic syndrome with excess blasts · acute biphenotypic leukemia · acute erythroid leukemia · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with t(8;21)(q22;q22) translocation · acute myeloid leukemia, del(5q31-q32) · acute myeloid leukemia, t(16;16)(p13.1;q22) · acute promyelocytic leukemia
+18 more
· chronic myeloid leukemia · acute lymphoblastic leukemia · acute megakaryoblastic leukemia · acute megakaryoblastic leukemia in adult · acute myeloblastic leukemia with maturation · acute myeloblastic leukemia without maturation · acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) · acute myeloid leukemia with minimal differentiation · acute myeloid leukemia, inv(16)(p13.1;q22) · acute myelomonocytic leukemia M4 · adult acute monocytic leukemia · childhood acute lymphoblastic leukemia · childhood acute myeloid leukemia · childhood myelodysplastic syndrome · leukemia, myeloid, accelerated-phase · myelodysplastic syndrome · Philadelphia-positive myelogenous leukemia · refractory anemia with excess blasts in transformation
Investigated by: Nohla Therapeutics, Inc. · Fred Hutchinson Cancer Center · National Cancer Institute (NCI) · National Heart, Lung, and Blood Institute (NHLBI)

201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT01031368	Dec 2009 → Sep 2012	acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +9	Nohla Therapeutics, Inc.	Completed	No outcome recorded
Phase 25 trials
Phase 2	NCT04083170	Oct → Nov 2022	HIV infectious disease, acute erythroid leukemia, acute lymphoblastic leukemia, acute megakaryoblastic leukemia +2	Fred Hutchinson Cancer Center	Terminated	No outcome recorded
Phase 2	NCT03399773	May 2022 → Jun 2025 overdue	Philadelphia-positive myelogenous leukemia, acute biphenotypic leukemia, myelodysplastic syndrome with excess blasts	Fred Hutchinson Cancer Center	Active not recruiting	No outcome recorded
Phase 2	NCT03301597	Jan 2018 → Mar 2019	acute myeloid leukemia	Nohla Therapeutics, Inc.	Terminated	No outcome recorded
Phase 2	NCT01690520	Dec 2012 → Sep 2018	acute biphenotypic leukemia, chronic myeloid leukemia, myelodysplastic syndrome	Nohla Therapeutics, Inc.	Completed	No outcome recorded
Phase 2	NCT01175785	Aug 2010 → Aug 2014	acute myeloid leukemia with 11q23 abnormalities, acute myeloid leukemia with t(8;21)(q22;q22) translocation, acute myeloid leukemia, del(5q31-q32), acute myeloid leukemia, inv(16)(p13.1;q22) +8	Nohla Therapeutics, Inc.	Completed	No outcome recorded

Every value below carries the sentence it was read from. 7 sources stand behind the page.

Field	Value	Cited text
Known as	Dilanubicel	“Dilanubicel” NCT01031368 ↗ 4 “Dilanubicel” NCT01690520 ↗ “Dilanubicel” NCT01175785 ↗ NCT03399773 ↗ NCT04083170 ↗
Known as	NLA101	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03301597 ↗
Action	Restore	“Assess the ability of the product to provide temporary myeloid engraftment.” NCT01031368 ↗
Modality	Cell therapy	“Infusion of a non-HLA-matched ex-vivo expanded cord blood progenitor cell product” PMID 27374466 ↗ Jun 2016
Route	Intravenous	“receive ex vivo-expanded cord blood progenitor cells IV over 4 hours” NCT01175785 ↗