Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes for Disease

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Mississippi Medical Center, Jackson, MS
Disease+8 More
Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes - Biological
Eligibility
< 65
All Sexes
Eligible conditions
Disease

Study Summary

This study is evaluating whether a combination of rituximab and LMP-specific T-cells may be more effective than rituximab alone in treating pediatric solid organ recipients with post-transplant lymphoproliferative disorder.

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Eligible Conditions

  • Disease
  • Lymphoproliferative Disorders
  • Monomorphic Post-Transplant Lymphoproliferative Disorder
  • Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder
  • Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
  • Polymorphic Post-Transplant Lymphoproliferative Disorder
  • Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder
  • Refractory Monomorphic Post-Transplant Lymphoproliferative Disorder
  • Refractory Polymorphic Post-Transplant Lymphoproliferative Disorder

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes will improve 2 primary outcomes and 16 secondary outcomes in patients with Disease. Measurement will happen over the course of Up to week 3.

Day 42
Percentage of Patients Successfully Matched to a Latent Membrane Protein (LMP)-Specific T Cell Product Derived From a Third Party LMP-specific T Cell Bank
Percentage of patients successfully matched to a latent membrane protein (LMP)-specific T cell product derived from a third party LMP-specific T cell bank
Day 42
Percentage of Patients Assigned to Arm Latent Membrane Protein-specific T-cells (LMP-TC) With Successful LMP-specific T Cell Product Match, Were Treated Within Two Weeks of the Expected Start Date, and Received Both Weekly Doses
Percentage of patients assigned to Arm latent membrane protein-specific T-cells (LMP-TC) with successful LMP-specific T cell product match, were treated within two weeks of the expected start date, and received both weekly doses
Month 12
Event-free Survival (EFS)
Event-free survival (EFS)
Overall Survival (OS)
Overall survival (OS)
Progression-free Survival
Progression-free survival
Up to 12 months
Absence of Epstein-Barr Virus Viremia
Absence of Epstein-Barr virus viremia
Incidence of Adverse Events
Incidence of adverse events
Up to week 3
Response Rate (RR) to Rituximab
Response rate (RR) to rituximab
Up to week 6
Response Rate (RR) to LMP-specific T Cells
Response rate (RR) to LMP-specific T cells

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Arm I (RTX)

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (RTX)
Biological
Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction.
Arm II (LMP-TC)Patients with newly diagnosed PTLD who do not achieve a CR to induction, all relapsed patients after induction, and all patients with refractory disease who received rituximab or biosimilar within 90 days according to institutional guidelines, receive allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes IV over 1- 2 minutes on days 0 and 7. Cycle continues for up to 42 days in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after first cycle of cycle allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes receive an additional cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

University of Mississippi Medical Center - Jackson, MS

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Disease or one of the other 8 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1
Patients must have a life expectancy of >= 8 weeks
Patient must have a history of solid organ transplantation
CD20 positive
EBV positive by Epstein-Barr virus early ribonucleic acid (RNA) (EBER) in situ hybridization (preferred) and/or LMP immunoperoxidase staining
There must be evaluable disease at study entry either by imaging or by serial endoscopic biopsies.
Note: a measurable node must have an LDi (longest diameter) greater than 1.5 cm; a measurable extranodal lesion should have an LDi greater than 1.0 cm; all tumor measurements must be recorded in millimeters (or decimal fractions of centimeters)
Patients must be considered medically refractory to decreased immunosuppression (50% or greater reduction) for at least 1 week or there must be documentation in the medical chart that decreased immunosuppression would be associated with an unacceptable risk of rejection
Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get disease a year in the United States?

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around 2 million Americans have at least a single disabling condition each year, including 4 million with multiple disabling conditions. The number of diseased individuals is relatively high. The proportion of disability attributable to the condition is relatively low, with over 85% of disability being attributable to other factors. The proportion of disabling conditions for which the cause cannot be identified and for which the cause is not known exceeds 15%. For conditions where the aetiology is recognised, many, including around a third, remain undiagnosed. Many diseased individuals have many conditions and may need some form of healthcare support in the course of their lives.

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What are common treatments for disease?

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The main and very common treatment is medication, specifically for depression, anxiety, and insomnia. The most commonly prescribed diseases are back pain and irritable bowel syndrome. The most commonly prescribed treatments were medication and physical therapy. Many medicines (particularly antidepressants, oral contraceptives, and hormonal contraception) may cause depression if taken in large doses over an extended time period. There is no cure for a large portion of common diseases. The common treatment is medication. However, it's not always necessary in all cases.

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Can disease be cured?

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A patient's chances of being cured if they have the disease remain small, but they are still good. For many patients it is a boon that they can experience relief of symptoms for at least a few weeks. For a minority, it can be a boon and the disease can be cured. These patients should also be considered as 'not-cured' and need to be treated.

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What is disease?

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Disease is an integral component of medical thinking and understanding. Disease is often associated with the term illness. While the terms ‘disease’ and ‘illiness’ are not in complete agreement, they provide a clear foundation for understanding medical conditions such as cancer. The use of the term illness to describe illness is, therefore, in accordance with American medical usage.

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What causes disease?

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It is unclear what causes disease. There must be a causal link between insult to the body and the disease process. It is likely that many diseases and diseases are due to a series of insults that causes damage to the body. In the case of diabetes and hypertension, many cause physical (trauma) and physiological (lack of oxygen) damage. In the case of asthma, damage may be due to immune system and other processes, particularly damage to the airways caused by an inhalant toxin. Understanding what happens at the molecular level that causes damage may help us to understand disease process.

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What are the signs of disease?

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The most common sign of disease in this study was visual disturbances. Symptoms included blurry vision, visual flashes, or dark spots in vision. However, the vast majority of patients with disorders did not show this symptom as a result of disease. The most significant sign of disease was hearing loss, in many patients. The most common sign of hearing loss was ringing in the ear, especially if it is caused by earwax. Eye abnormalities are also common in disease. Some patients suffered from swollen eyelids, tired eyes, or blepharitis. Many patients also complained of dry and itchy eyes. The most common abnormal sign of eyesight in patients were myopia and retinopathy. Patients also had some sign of skin abnormalities.

Unverified Answer

What is the primary cause of disease?

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There is no clear association between genotype and disease phenotypes for a given genetic variant. For each variant, however, more than one disease phenotype is observed, highlighting the impact of genetic and environmental factors.

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Does allogeneic lmp1/lmp2-specific cytotoxic t-lymphocytes improve quality of life for those with disease?

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Findings from a recent study provides a proof of concept and suggests that allogeneic lmp1/lmp2-specific cytotoxic t-lymphocytes are more effective than placebo for improving quality of life in patients with LMP1/LMP2-positive DLBCL. The mechanism(s) behind the therapeutic advantage of allogeneic versus autologous lmp1- and lmp2-specific CTLs requires further investigation.

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How does allogeneic lmp1/lmp2-specific cytotoxic t-lymphocytes work?

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We have identified lmp1/2-specific, CD5-negative effector-memory T cells with both cytotoxicity to APCs and function in vivo. These cells accumulate in the lymphoid organ and efficiently kill lmp1/2-stimulated APCs. As a consequence, these data suggest that lmp1/2-specific cytotoxic T cells can exert a potent antitumor effect against lmp1/2-expressing tumors.

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What does allogeneic lmp1/lmp2-specific cytotoxic t-lymphocytes usually treat?

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We show here that lmp1/lmp2-selective, allogeneic CTLs do not usually provide therapeutic benefit in solid tumors and that lmp1-specific CTLs are mainly effective against cutaneous T cell lymphoma. The relevance of these findings to the design of anticancer immunotherapy of patients with B cell lymphoma merits further evaluation.

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What are the common side effects of allogeneic lmp1/lmp2-specific cytotoxic t-lymphocytes?

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For the induction of leukemia in BALB/c allogeneic recipients, treatment with allogeneic CTL of any of the four different strains and methods, when given to BALB/c recipients, induce leukemia that manifests in a host/host-specific and in general lethal fashion.

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What is allogeneic lmp1/lmp2-specific cytotoxic t-lymphocytes?

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This indicates that CD56+ cells isolated from healthy donors may possess a specific allogeneic CTL activity. The induction of CTL response was more common in patients with MDS than in patients with cancer. Lmp1/2 may be potential target antigens for CTL preparation in MDS and cancer.

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