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Autologous AdE1- Latent Membrane Protein CTLs

Phase 1

Lymphoma | Monoclonal antibody | Oncology |Atlantic International Corp.|Last Updated: May 22, 2012

Success Probability

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

Autologous AdE1- Latent Membrane Protein CTLs · 1 trial · 1 indication

Phase 1 1
NCT00779337Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive LymphomasLymphoma
COMPLETED8 Analytics
PHASE1COMPLETED
Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas
LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Feasibility (generation of autologous clinical grade AdE1-LMP-specific CTL from the blood of EBV-positive lymphoma patients)
The investigational product for each participant will be assessed post production. The patient will have blood samples taken prior to and following each infusion, and then at 1, 3, 6 & 12 months following the final infusion.
Safety as assessed by adverse event monitoring. Patients will be questioned and toxicities recorded according to the International Common Toxicity Criteria.
1 hour post 4 AdE1-LMP CTL injections (injections are weekly for first 10 participants & twice weekly for the next 10 participants), 3-5 weeks post the 4th injection, then 3, 6 and 12 months post the 4th injection
Reconstitution of EBV-specific CTL immunity with anti-viral efficacy measured by immunological & virological assessment of blood samples including immunophenotyping, intracellular cytokine assays, CD107 cytotoxicity assays and EBV DNA load analysis.
At baseline, pre and 1 hour post 4 AdE1-LMP CTL injections, 3-5 weeks post the 4th injection, then 3, 6 and 12 months post the 4th injection

Secondary Endpoints

Optimal dose intensity of the intervention. Clinical efficacy (radiological assessment by CT), biological efficacy (reconstitution of EBV-specific CTL immunity & anti-viral efficacy), safety & efficacy of the 1st treatment schedule vs the 2nd schedule
Clinical evaluation, AE monitoring & collection of blood samples at baseline, pre & 1 hr post injections, 3-5 weeks, 3, 6 and 12 months post 4th injection. Radiological examination at baseline & at 3 to 5 wks & 3 months post the 4th treatment.
Clinical efficacy
CT scan +/- additional scans at baseline , 3-5 weeks & 3 months post the 4th injection. Clinical evaluation at baseline, pre and 1 hour post injections, 3-5 weeks, 3, 6 and 12 months post the 4th injection
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single group studyEXPERIMENTALAutologous AdE1- Latent Membrane Protein (LMP) Cytotoxic T Lymphocytes.

Interventions

NameTypeDescription
Autologous AdE1- Latent Membrane Protein CTLsBIOLOGICALTotal dose 20-800 million CTL given in 4 equal doses (5-200 million CTL) given intravenously, at weekly intervals for the first cohort of 10 patients and twice a week for the second cohort of 10 patients.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Informed consent. * EBV-positive lymphoma as determined by in situ hybridization or equivalent (excluding Burkitts Lymphoma). * Age 18 years or older. * ECOG performance status 1, 2 or 3 * Life expectancy of at least 6 months. * Measurable disease: either relapsing, partially ...

Countries:Australia
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Competitive Landscape -Lymphoma 338 trials

Top 20 of 66 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
AstraZeneca PLCAZN14PHASE3Surovatamig, R-CHOP, R-CVP, BR
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles, Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC20PHASE3BGB-16673, Bendamustine, Rituximab, Methylprednisolone, Chlorambucil
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide
Bristol-Myers Squibb CompanyBMY17PHASE3Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Johnson & JohnsonJNJ11PHASE3Ibrutinib
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK6PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone
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Frequently asked questions about Autologous AdE1- Latent Membrane Protein CTLs

What is Autologous AdE1-Latent Membrane Protein CTLs used for?

Autologous AdE1-Latent Membrane Protein CTLs is an investigational cell therapy being studied for the treatment of lymphoma. It is currently in Phase 1 clinical development for this indication. The therapy is designed for patients with Epstein-Barr virus (EBV)-positive lymphomas, as it uses EBV-specific T cells to target the disease.

Who is developing Autologous AdE1-Latent Membrane Protein CTLs?

Autologous AdE1-Latent Membrane Protein CTLs is being developed by Atlantic International Corp., a company traded under the ticker symbol ATLN. The therapy is in Phase 1 clinical development for the treatment of lymphoma.

What phase is Autologous AdE1-Latent Membrane Protein CTLs in?

Autologous AdE1-Latent Membrane Protein CTLs is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. A Phase 1 clinical trial for this therapy has been completed, with results not yet reported.

What clinical trials is Autologous AdE1-Latent Membrane Protein CTLs in?

Autologous AdE1-Latent Membrane Protein CTLs has been studied in one completed Phase 1 clinical trial, identified as NCT00779337. This trial, titled 'Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas,' enrolled 8 participants in Australia and was not randomized or blinded.

Is Autologous AdE1-Latent Membrane Protein CTLs the same as EBV-specific T cells?

Autologous AdE1-Latent Membrane Protein CTLs is a type of EBV-specific T cell therapy. The clinical trial NCT00779337 describes it as EBV-specific T cells used as therapy for relapsed or refractory EBV-positive lymphomas. This therapy is designed to target EBV-positive lymphoma cells.