A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas

To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

Start Date01 Nov 2016

Sponsor / Collaborator

Kuur Therapeutics Ltd.

NCT01948180

/ TerminatedPhase 2

A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)

To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma

Start Date01 Sep 2014

Sponsor / Collaborator

Kuur Therapeutics Ltd.

100 Clinical Results associated with Baltaleucel-T (CAGT/Kuur Therapeutics)

100 Translational Medicine associated with Baltaleucel-T (CAGT/Kuur Therapeutics)

100 Patents (Medical) associated with Baltaleucel-T (CAGT/Kuur Therapeutics)

Literatures (Medical) associated with Baltaleucel-T (CAGT/Kuur Therapeutics)

01 Oct 2021·Annals of HematologyQ3 · MEDICINE

Autologous EBV-specific T cell treatment results in sustained responses in patients with advanced extranodal NK/T lymphoma: results of a multicenter study

Q3 · MEDICINE

Article

Author: Murray, Maryann ; Suh, Cheolwon ; Combs, Katherin E ; Lee, Hun Ju ; Lee, Daniel Y ; Suarez, Felipe ; Budde, Lihua E ; Bollard, Catherine M ; Radford, John ; Heslop, Helen E ; Kim, Jin Seok ; Inman, Shannon ; Kim, Seok Jin ; Yoon, Sang Eun ; Gunter, Kurt C ; Oki, Yasuhiro ; Rooney, Cliona M ; Jacobsen, Eric D ; Bachy, Emmanuel ; Yoon, Dok Hyun ; Kim, Won Seog ; Ardeshna, Kirit M ; Ruan, Jia ; Kang, Hye Jin ; Lin, Yi ; Brammer, Jonathan E ; Jaccard, Arnaud ; Porcu, Pierluigi ; Advani, Ranjana

We conducted a phase II clinical trial to develop an autologous EBV-specific T cell product (baltaleucel T) for advanced, relapsed ENKTL. Among 47 patients who provided whole blood starting material for manufacturing the product, 15 patients received a median of 4 doses of baltaleucel T. Thirty-two (68%) patients did not receive baltaleucel-T due to manufacturing failure, rapid disease progression, and death. Of the 15 patients, 10 patients had measurable disease at baseline (salvage cohort), and 5 patients had no disease at baseline assessment (adjuvant cohort). In the 15 patients, the median follow-up duration was 10.2 months (range 2.0-23.5 months), median progression-free survival (PFS) was 3.9 months, and the median overall survival (OS) was not reached. Patients in the salvage cohort achieved a 30% complete response (CR) and a 50% overall response rate (ORR). In the adjuvant cohort, disease progression was reported in three patients and two patients did not relapse during study follow-up. When we compared survival outcomes of seven responders and eight non-responders, the PFS (P = 0.001) and OS (P = 0.014) of responders proved statistically superior to that of non-responders. Baltaleucel-T was well tolerated. We have performed a phase II clinical trial of autologous EBV-specific T cell treatment (baltaleucel-T) in R/R ENKTL. Autologous EBV-specific T cells were well tolerated and demonstrated single-agent activity in R/R ENTKL.

100 Deals associated with Baltaleucel-T (CAGT/Kuur Therapeutics)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	Phase 2	United States	Kuur Therapeutics Ltd.	01 Nov 2016
Hodgkin's Lymphoma	Phase 2	United States	Kuur Therapeutics Ltd.	01 Nov 2016
Post-transplant lymphoproliferative disorder	Phase 2	United States	Kuur Therapeutics Ltd.	01 Nov 2016
Extranodal NK-T-Cell Lymphoma	Phase 2	France	Kuur Therapeutics Ltd.	01 Sep 2014
Extranodal NK-T-Cell Lymphoma	Phase 2	South Korea	Kuur Therapeutics Ltd.	01 Sep 2014
Extranodal NK-T-Cell Lymphoma	Phase 2	United States	Kuur Therapeutics Ltd.	01 Sep 2014
Extranodal NK-T-Cell Lymphoma	Phase 2	United Kingdom	Kuur Therapeutics Ltd.	01 Sep 2014
Nasopharyngeal Neoplasms	Phase 2	United States	Baylor College of Medicine	09 Nov 2009
Epstein-Barr Virus Infections	Phase 2	United States	Center For Cell & Gene Therapy	-
Epstein-Barr Virus Infections	Phase 2	United States	Center For Cell & Gene Therapy	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02763254 (CIVIC, CTgov)	Phase 2	Hodgkin's Lymphoma \| Post-transplant lymphoproliferative disorder \| Epstein-Barr Virus-Related Lymphoma \| Diffuse Large B-Cell Lymphoma	1	baltaleucel-T	ryhanuafwy(frnxdwqggg) = swlrvlfipd hxpfnblqhb (fkgozlrvve, jjlzsyrxfw - vpokzoabed) View more	-	12 Mar 2019
NCT01948180 (CITADEL, SITC2018)	Phase 2	Extranodal NK-T-Cell Lymphoma Adjuvant EBV expression	15	Baltaleucel T	uggqsabeav(drhuxwuryx) = qgjycyqgsf teltgmjsgg (zrmbcikxdl ) View more	Positive	06 Nov 2018

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