Delving into the Latest Updates on Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics) with Synapse

Overview

Basic Info

Drug Type

T-lymphocyte cell therapy

Synonyms-

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsMouth and Tooth DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication-

Inactive Indication

Advanced Nasopharyngeal CarcinomaNasopharyngeal Carcinoma

Originator Organization

Tessa Therapeutics Ltd

Active Organization-

Inactive Organization

Tessa Therapeutics Ltd

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

Login to view timeline

This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients.
Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T cells (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30 hospital centers across Asia and the United States.
This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma".

Start Date01 Jul 2014

Sponsor / Collaborator

Tessa Therapeutics Ltd

NCT00078546

/ CompletedPhase 1IIT

Administration of EBV-Specific Cytotoxic T Lymphocytes Following CD45 Antibody to Patients With EBV Positive Nasopharyngeal Carcinoma

To determine the safety of the combination of CD45 monoclonal antibody (Mab) followed by intravenous injection of EBV specific CTL in patients with nasopharyngeal cancer.
To compare the expansion, persistence and anti-tumor effects of the EBV specific CTL given after CD45 Mab administration with that observed in our first study.
To obtain preliminary information on the safety and response to an extended dosage regimen of EBV-specific CTL in patients, who have stable disease or a partial response after the initial dose of EBV-specific CTL.

Start Date01 Sep 2003

Sponsor / Collaborator

Baylor College of Medicine

[+2]

NCT00609219

/ CompletedPhase 1IIT

Administration of EBV-Specific T-Lymphocytes to Patients With EBV-Positive Nasopharyngeal Carcinoma

Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not gone away or is at high risk for coming back after treatment (including the best treatment we know for nasopharyngeal cancer). We are asking patients to volunteer to be in a research study using special immune system cells called EBV-specific cytotoxic T lymphocytes, a new experimental therapy.
Most patients with nasopharyngeal cancer show evidence of infection with the virus that causes infectious mononucleosis, Epstein Barr virus (EBV), before or at the time of their diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with nasopharyngeal cancer, suggesting that it may play a role in causing this cancer. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells (called T cells) that have been trained to kill EBV-infected cells can survive in the patient's blood and affect the tumor.
We have treated other patients with different EBV positive cancers and have had variable results. Some patients have had some response to the treatment. Some patients have been cured by the treatment. It is not possible for us to predict if this treatment will work for nasopharyngeal cancer.
The purposes of this study are to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are, and to see whether this therapy might help patients with nasopharyngeal cancer.

Start Date01 Aug 2001

Sponsor / Collaborator

Baylor College of Medicine

[+2]

100 Clinical Results associated with Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics)

Login to view more data

100 Translational Medicine associated with Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics)

Login to view more data

100 Patents (Medical) associated with Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics)

Login to view more data

11

Literatures (Medical) associated with Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics)

01 Dec 2024·ANNALS OF ONCOLOGY

Gemcitabine, carboplatin, and Epstein–Barr virus-specific autologous cytotoxic T lymphocytes for recurrent or metastatic nasopharyngeal carcinoma: VANCE, an international randomized phase III trial

Article

Author: Hasbullah, H.H. ; Wirasorn, K ; Lulla, P. ; Sirachainan, E ; Brenner, M.K. ; Samol, J. ; Horak, I ; Ding, C. ; Ang, M K ; Ho, G F ; Algazi, A ; Wang, H.-M. ; Liu, Y C ; Toh, H C ; Ho, K F ; Toh, H.C. ; Myo, A. ; Wang, W.-W. ; Yang, M-H ; Wirasorn, K. ; Lertbutsayanukul, C. ; Ho, G.F. ; Ho, K.F. ; Wirth, L J ; Low, S.H.J. ; Tan, S H ; Tho, L M ; Nadler, E ; Wang, H-M ; Ding, C ; Low, S H J ; Colevas, A.D. ; Hong, R.-L. ; Ang, S F ; Chitapanarux, I. ; Nadler, E. ; Chitapanarux, I ; Brenner, M K ; Tho, L.M. ; Tan, S.H. ; Ang, S.F. ; Hsieh, C Y ; Liu, Y.C. ; Lulla, P ; Ang, M.K. ; Ong, W S ; Hsieh, C.Y. ; Myo, A ; Lertbutsayanukul, C ; Sirachainan, E. ; Yang, M.-H. ; Colevas, A D ; Samol, J ; Hong, R-L ; Wirth, L.J. ; Wang, W-W ; Ong, W.S. ; Horak, I. ; Algazi, A. ; Hasbullah, H H

BACKGROUND:

Epstein-Barr virus-specific cytotoxic T lymphocyte (EBV-CTL) is an autologous adoptive T-cell immunotherapy generated from the blood of individuals and manufactured without genetic modification. In a previous phase II trial of locally recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) patients, first-line gemcitabine and carboplatin (GC) and EBV-CTL combination demonstrated objective antitumor EBV-CTL activity and a favorable safety profile. The present study explored whether this combined first-line chemo-immunotherapy strategy would produce superior clinical efficacy and better quality of life compared with conventional chemotherapy treatment.

PATIENTS AND METHODS:

This multicenter, randomized, phase III trial evaluated the efficacy and safety of GC followed by EBV-CTL versus GC alone as first-line treatment of R/M NPC patients. Thirty clinical sites in Singapore, Malaysia, Taiwan, Thailand, and the USA were included. Subjects were randomized to first-line GC (four cycles) and EBV-CTL (six cycles) or GC (six cycles) in a 1 : 1 ratio. The primary outcome was overall survival (OS) and secondary outcomes included progression-free survival, objective response rate, clinical benefit rate, quality of life, and safety.

CLINICALTRIALS:

gov identifier: NCT02578641.

RESULTS:

A total of 330 subjects with NPC were enrolled. Most subjects in both treatment arms received four or more cycles of chemotherapy and most subjects in the GC + EBV-CTL group received two or more infusions of EBV-CTL. The central Good Manufacturing Practices (GMP) facility produced sufficient EBV-CTL for 94% of GC + EBV-CTL subjects. The median OS was 25.0 months in the GC + EBV-CTL group and 24.9 months in the GC group (hazard ratio = 1.19; 95% confidence interval 0.91-1.56; P = 0.194). Only one subject experienced a grade 2 serious adverse event related to EBV-CTL.

CONCLUSIONS:

GC + EBV-CTL in subjects with R/M NPC demonstrated a favorable safety profile but no overall improvement in OS versus chemotherapy. This is the largest adoptive T-cell therapy trial reported in solid tumors to date.

01 Aug 2022·Zhongguo shi yan xue ye xue za zhi

[Clinical Analysis of Post-Transplant Lymphoproliferative Disorder after Hematopoietic Stem Cell Transplantation in Severe Aplastic Anemia Patients].

Article

Author: Ding, Li ; Yan, Hong-Min ; Wang, Heng-Xiang ; Han, Dong-Mei ; Xue, Mei ; Zhu, Ling ; Li, Sheng ; Liu, Jing ; Zheng, Xiao-Li

OBJECTIVE:

To analyze the clinical characteristics of SAA patients with post-transplantation lymphoproliferative disease (PTLD) after allogeneic hematopoietic stem cell transplantation, and to improve diagnosis and treatment of PTLD.

METHODS:

The clinical data of 192 patients with SAA patients who underwent HSCT in a single center from September 2010 to September 2017 were analyzed retrospectively. All patients were received antithymocyte globulin（ATG） conditioning regimen and mesenchymal stem cell(MSC) infusion.

RESULTS:

Among 192 cases, PTLD occurred in 14 cases, the incidence was 7.29％， 9 of them were diagnosed by pathology， and 5 were diagnosed clinically. EBV infection occurred with a median time of 72（35-168） days, Viral load higher than 1×10⁴ copies/ml occured in all PTLD patients. The incidence of probable PTLD in patients ≤12 years old and ＞12 years old was 11.11%, 2.38%, respectively (P<0.01）. Univariate and multivariate analysis that the EBV infection, patients age≤12 years old, HLA-mismatch in URD-HSCT, grade II to IV aGVHD were the independent risk factors for PTLD. All PTLD patients were treated with rituximab(RTX) when EBV-DNA load higher than 1×10⁴ copies/ml, or reducted the use of immunosuppression(RIS), patients with poor therapeutic effect were treated combined with EBV-specific CTLs(EBV-CTL) and chemotherapy. All patients were treated effectively, and the total effective rate was 100％. The median follow-up time was 65(62-115) months, and the overall survival rate was 92.85%. One patients died of cerebral hemorrhage, 7 months after PTLD curred.

CONCLUSION:

The incidence of PTLD after HSCT with SAA who used ATG and MSC in conditioning regimen closely relates to EBV infection, age of patients≤12 years, HLA-mismatch in URD-HSCT, grade II to IV GVHD. Rituximab combined with RIS may reduce the incidence of PTLD, combined EBV-CTL and chemotherapy may be the useful and most important treatment for PTLD.

01 Dec 2021·Transplant international : official journal of the European Society for Organ TransplantationQ2 · MEDICINE

EBV‐specific cytotoxic T lymphocytes for refractory EBV‐associated post‐transplant lymphoproliferative disorder in solid organ transplant recipients: a systematic review

Q2 · MEDICINE

Review

Author: Wei, Lin ; Zhang, Jin‐Ming ; Liu, Jing‐Yi ; Sun, Li‐Ying ; Zhan, Hao‐Su

The use of Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs) in adoptive immunotherapy in hematopoietic stem cell transplantation (HSCT) patients with post-transplantation lymphoproliferative disorder (PTLD) has demonstrated safety and effectiveness. EBV-CTLs might also be the effective treatment of refractory PTLD of solid organ transplantation (SOT) recipients. Two independent assessors searched Pubmed, Embase, Cochrane Library, and Web of Science from their inception to November 2020. Eleven studies with 76 patients (42, 55% male) were included. We extracted the data and completed the quality assessments. Most of the studies were from Europe and the USA. Liver and kidney transplantation accounted for most of the transplant types. Thirty-five (46.1%) patients were diagnosed with monomorphic PTLD, and B lymphocyte type was the most common. All the patients received primary treatment for PTLD while it was ineffective. CTLs included autologous EBV-CTLs (15/76, 22%) and HLA-matched third-party EBV-CTLs (61/76, 78%). The response rate for EBV-CTL treatment of refractory PTLD was 66%. Of 50 patients, 36 achieved complete remission and 14 achieved partial remission. EBV-DNA level decreased in 39 patients. Adverse reactions were rare and mild. We conclude that adoptive therapy with EBV-specific CTLs is safe, well-tolerated, and effective in PTLD.

100 Deals associated with Autologous EBV specific Cytotoxic T cells(Tessa Therapeutics)

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Nasopharyngeal Carcinoma	Phase 3	United States	Tessa Therapeutics Ltd	01 Jul 2014
Advanced Nasopharyngeal Carcinoma	Phase 3	Malaysia	Tessa Therapeutics Ltd	01 Jul 2014
Advanced Nasopharyngeal Carcinoma	Phase 3	Singapore	Tessa Therapeutics Ltd	01 Jul 2014
Advanced Nasopharyngeal Carcinoma	Phase 3	Taiwan Province	Tessa Therapeutics Ltd	01 Jul 2014
Advanced Nasopharyngeal Carcinoma	Phase 3	Thailand	Tessa Therapeutics Ltd	01 Jul 2014
Nasopharyngeal Carcinoma	Phase 3	United States	Tessa Therapeutics Ltd	01 Jul 2014
Nasopharyngeal Carcinoma	Phase 3	Malaysia	Tessa Therapeutics Ltd	01 Jul 2014
Nasopharyngeal Carcinoma	Phase 3	Singapore	Tessa Therapeutics Ltd	01 Jul 2014
Nasopharyngeal Carcinoma	Phase 3	Taiwan Province	Tessa Therapeutics Ltd	01 Jul 2014
Nasopharyngeal Carcinoma	Phase 3	Thailand	Tessa Therapeutics Ltd	01 Jul 2014

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02287311 (MABEL, CTgov)	Phase 1	Smooth Muscle Tumor \| Hodgkin's Lymphoma \| Epstein-Barr Virus-Related Lymphoma ... View more	38	EBV (Group A Cohort 1)	jbjbyjsrfz = rqmvujrbld cprdltuhbz (gcjtoosldx, phcrnsshxn - ppxzowufoy) View more	-	24 Feb 2025
				EBV (Group A Cohort 2)	jbjbyjsrfz = ktxmwenlby cprdltuhbz (gcjtoosldx, ftlczasrlo - gqyxypjehm) View more
NCT02578641 (VANCE, Pubmed \| Ann Oncol) Manual	Phase 3	Nasopharyngeal Carcinoma First line	330	Gemcitabine ancarboplatinin EBV-CTLEBV-CTL	ykzevruhhm(cstjpclstg) = ofocgimovm dbsuwarjug (asyvvltsbl )	Negative	01 Sep 2024
				Gemcitabine carboplatinatin (GC)	ykzevruhhm(cstjpclstg) = vwxcvakzkz dbsuwarjug (asyvvltsbl )
NCT02578641 (VANCE, CTgov)	Phase 3	Nasopharyngeal Carcinoma \| Advanced Nasopharyngeal Carcinoma	330	carboplatin+gemcitabine (Chemo + EBV-CTL)	kkcimlcmaf(smrwzlosxl) = mgekbdaqcf ovzpsmmyfp (gwpaxuqomp, brrqyxnxth - swuteuyukw) View more	-	28 Jun 2023
				carboplatin+gemcitabine (Chemo Only)	kkcimlcmaf(smrwzlosxl) = fphuskeygf ovzpsmmyfp (gwpaxuqomp, oqvxnhihdb - utgpaayglu) View more
Tandem Meetings ASTCT and CIBMTR2008	Not Applicable	Epstein-Barr virus associated Nasopharyngeal Carcinoma	-	Adoptively Transferred Cytotoxic T Lymphocytes (EBV-specific CTL)	zbprjdisug(qdxklxenpi) = Transient swelling at known disease sites in 4 patients zmkvgqnkfb (kqkpexufau )	-	01 Feb 2008
				Adoptively Transferred Cytotoxic T Lymphocytes (CD45 MAbs)