drugset
Drugs / UCART123
last change May 2023 re-read 3 minutes ago

UCART123

Cell therapy

Developed for
acute myeloid leukemia · CD4+/CD56+ hematodermic neoplasm
Investigated by
Cellectis S.A.

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Clinical hold US (FDA) — acute myeloid leukemia with NPM1-MLF1 fusion 2017-09-04

“the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on both Phase I trials of UCART123.” cellectis.com ↗

“received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold was placed on both UCART123 ongoing Phase 1 studies” cellectis.com ↗

Trials 2

today NCT04106076 · Ph 1 NCT03203369 · Ph 1
2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT04106076 Jul → Dec 2019 acute myeloid leukemia Cellectis S.A. Withdrawn No outcome recorded
Phase 1 NCT03203369 Jun 2017 → Jun 2019 CD4+/CD56+ hematodermic neoplasm Cellectis S.A. Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2023-05-17 Cellectis S.A. Results Cellectis Presents Clinical Data on AMELI-01 and Preclinical Data on Multiplex Engineering for Superior Generation of CAR T-cells at ASGCT 2023 cellectis.com ↗
The oral presentation reviewed preliminary data from patients who received UCART123 at one of the following dose levels:
2023-05-02 Cellectis S.A. Results Cellectis Announces Oral Presentation on AMELI-01 and Poster Presentation on Multiplex Engineering for Superior Generation of CAR T-cells at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting cellectis.com ↗
The data show that adding alemtuzumab to the FC regimen was associated with improved LD and significantly higher UCART123 cell expansion, which correlated with improved activity.
2022-12-13 Cellectis S.A. Results Cellectis Announces Positive Preliminary Clinical Data for UCART22 in ALL and UCART123 in AML cellectis.com ↗
UCART123: 25% (n=2) of patients at DL2 in the FCA arm achieved meaningful response; one patient experienced a durable minimal residual disease (MRD)-negative complete response that continues beyond 12 months
2022-11-03 Cellectis S.A. Results Cellectis to Showcase Clinical Data from AMELI-01 and Preclinical Data from UCARTCS1 at ASH 2022 cellectis.com ↗
These data are encouraging and support the continued enrollment into the study.
2022-04-28 Cellectis S.A. Results Cellectis Publishes Two Articles in Nature Communications Providing Strong Preclinical Validation of UCART123 to Treat AML and BPDCN cellectis.com ↗
These preclinical data demonstrate the robust in vitro and in vivo activity of UCART123 and provide pre-clinical proof of concept for an allogenic CART cell approach to tackle AML.
2019-11-06 Cellectis S.A. Regulatory Cellectis Reports Financial Results for Third Quarter and First Nine Months 2019 cellectis.com ↗
Grant of a new IND for UCART123 following a change in production process
2018-05-22 Cellectis S.A. Regulatory Approval of UCART123 Amendment in AML to Accelerate Clinical Development cellectis.com ↗
2017-11-07 Cellectis S.A. Regulatory FDA Lifts Clinical Hold on Cellectis Phase 1 Clinical Trials with UCART123 in AML and BPDCN cellectis.com ↗
2017-09-05 Cellectis S.A. Regulatory Cellectis Reports Clinical Hold of UCART123 Studies cellectis.com ↗
2017-02-06 Cellectis S.A. Regulatory FDA Grants Cellectis IND Approval to Proceed with the Clinical Development of UCART123, the First Gene Edited Off-the-Shelf CAR T-Cell Product Candidate developed in the U.S. cellectis.com ↗
This marks the first allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials.
2017-01-03 Cellectis S.A. Regulatory Cellectis Submits IND Application for UCART123, an Allogeneic Gene Edited CAR T-Cell Product Candidate, in AML and BPDCN cellectis.com ↗
2016-12-15 Cellectis S.A. Regulatory Cellectis Announces Recombinant DNA Advisory Committee’s (RAC) Unanimous Approval of UCART123 Phase 1 Study Protocols in AML and BPDCN cellectis.com ↗

All press releases naming this drug 17 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as UCART123 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03203369 ↗
1

NCT04106076 ↗
Modality Cell therapy “Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor” NCT03203369 ↗
Route Intravenous “A single intravenous administration of UCART123.” NCT03203369 ↗