17:38 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

Cell Medica doses first neuroblastoma patient with NK cell therapy

Cell Medica Ltd. (London, U.K.) dosed the first patient in the open-label, U.S. Phase I GINAKIT2 trial of CMD-501 to treat relapsed or refractory pediatric neuroblastoma, which the company said marks the first use of...
00:00 , Mar 7, 2018 |  BC Extra  |  Clinical News

GlycoMimetics falls on Phase III AML trial design

GlycoMimetics Inc. (NASDAQ:GLYC) lost $4.07 (18%) to $18.75 on Tuesday after the company unveiled late Monday the design of its Phase III trial for acute myelogenous leukemia candidate GMI-1271. The primary endpoint of the trial,...
02:15 , Dec 16, 2017 |  BioCentury  |  Product Development

Assessing the BCMA scene

Differences in patient populations and a dearth of clinical outcome data mean it’s too soon to declare bluebird bio Inc.’s anti-BCMA chimeric antigen receptor therapy the leader of the pack of CARs that presented clinical...
20:46 , Nov 17, 2017 |  BC Week In Review  |  Clinical News

FDA lifts clinical hold on Cellectis' CAR T candidate

Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) said FDA lifted a clinical hold on Phase I testing of its chimeric antigen receptor (CAR) T cell candidate UCART123 to treat acute myelogenous leukemia (AML) and blastic plasmacytoid dendritic cell...
02:19 , Nov 7, 2017 |  BC Extra  |  Clinical News

FDA lifts clinical hold on Cellectis' CAR T candidate

Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) said late Monday that FDA lifted a clinical hold on Phase I testing of its chimeric antigen receptor (CAR) T cell candidate UCART123 to treat acute myelogenous leukemia (AML) and blastic...
20:20 , Sep 8, 2017 |  BC Week In Review  |  Clinical News

FDA places hold on Phase I testing of Cellectis' CAR T UCART123

Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) said a patient death prompted FDA to place a clinical hold on Phase I testing of its chimeric antigen receptor (CAR) T cell candidate UCART123. The company said it is discussing...
21:53 , Sep 5, 2017 |  BC Extra  |  Clinical News

Cellectis plummets after CAR T death

Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) fell €5.67 (21%) to €21.17 in Europe and $6.52 (20%) to $25.66 on NASDAQ on Tuesday after a patient death prompted FDA to place a clinical hold on Phase I testing...
19:55 , Jun 9, 2017 |  BC Week In Review  |  Clinical News

CARsgen reports Phase I data for anti-GPC3 CAR T in HCC

CARsgen Therapeutics Co. Ltd. (Shanghai, China) reported preliminary data from 5 evaluable patients with relapsed or refractory hepatocellular carcinoma (HCC) in a Chinese Phase I trial showing that CSG-GPC3 following lymphodepleting conditioning with fludarabine and...
23:00 , Dec 14, 2016 |  BC Week In Review  |  Clinical News

Arzerra regulatory update

Genmab said the European Commission approved an expanded label for Arzerra ofatumumab from Novartis to include treatment of relapsed chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide. Arzerra is approved in the EU...
22:57 , Dec 14, 2016 |  BC Week In Review  |  Clinical News

NY-ESO-SPEAR T-cell therapy: Ph I/II started

Adaptimmune began an open-label, U.S. Phase I/II trial to evaluate a single IV infusion of NY-ESO-SPEAR T-cell therapy following preconditioning with fludarabine/cyclophosphamide in up to 15 patients with metastatic or inoperable MRCLS. The trial will...