Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664179
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2020-12-07
Brief Title:
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Constitutive IL7 C7R Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CILESTE
Brief Summary:
This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or TNK-lymphoproliferative disease which has come back or has not gone away after treatment including the best treatment the investigators know for these diseases
Some patients with Lymphoma or TNK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus EBV that causes mononucleosis or glandular fever mono before or at the time of their diagnosis EBV is found in the cancer cells of up to half the patients with Hodgkins and non-Hodgkin Lymphoma suggesting that plays a role in causing Lymphoma The cancer cells in lymphoma and some immune system cells infected by EBV are able to hide from the bodys immune system and escape destruction
T cells also called T lymphocytes are special infection-fighting blood cells that can kill other cells including cells infected with viruses and tumor cells T cells have been used to treat patients with cancers T cells that have been trained to kill EBV infected cells can survive in the blood and affect the tumor The investigators have treated over 80 people on studies using T cells to target these diseases About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses
The investigators think that if T cells are able to last longer in the body they may have a better chance of killing EBV and EBV infected tumor cells Therefore in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time
The purpose of this study is to find the largest safe dose of C7R-EBV T cells and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer
Some patients with Lymphoma or TNK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus EBV that causes mononucleosis or glandular fever mono before or at the time of their diagnosis EBV is found in the cancer cells of up to half the patients with Hodgkins and non-Hodgkin Lymphoma suggesting that plays a role in causing Lymphoma The cancer cells in lymphoma and some immune system cells infected by EBV are able to hide from the bodys immune system and escape destruction
T cells also called T lymphocytes are special infection-fighting blood cells that can kill other cells including cells infected with viruses and tumor cells T cells have been used to treat patients with cancers T cells that have been trained to kill EBV infected cells can survive in the blood and affect the tumor The investigators have treated over 80 people on studies using T cells to target these diseases About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses
The investigators think that if T cells are able to last longer in the body they may have a better chance of killing EBV and EBV infected tumor cells Therefore in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time
The purpose of this study is to find the largest safe dose of C7R-EBV T cells and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer
Detailed Description:
The patient will donate blood in order to make C7R-EBV T cells Depending on how long ago the cells were generated they have been frozen To get the C7R to be made by the T-cell the investigators inserted a gene into the T-cell This is done using certain parts of a virus known as a retrovirus that can carry the gene into the T cells Because patients receive cells with a new gene in them they will befollowed for a total of 15 years to see if there are any long term side effects of gene transfer
When they are enrolled in this study patients are assigned a dose of C7R EBV T cells The assigned dose of cells is based on body weight and height Patients will receive the C7R EBV T cells and may also receive cyclophosphamide and fludarabine these are standard chemotherapy medicines The chemotherapy medicines may be given before the T cells to make space in the blood for the T cells to grow after receiving them
If a patient receives chemotherapy medicines these drugs will be given through an iv needle inserted in the patients vein or central line for 2 days and then fludarabine alone on the third day The patient will be given an injection of C7R EBV T cells into the vein through an IV line at the assigned dose
Patients may receive Benadryl and Tylenol The infusion will take between 1 and 10 minutes The investigators will then monitor the patient in the clinic or hospital for about 2 hours The treatment will be given by the Center for Cell and Gene Therapy at Texas Childrens Hospital or Houston Methodist Hospital Patients should plan to stay in Houston for up to 2 weeks after the infusion so the investigators can monitor them for side effects
Patients will have follow-up visits with the clinic at scheduled visits weeks 2 and 6 and nursing follow-up at weeks 1 2 4 and 6 months 3 6 9 and 12 and annually for the next 15 years Patients will have scheduled disease evaluations after the T-cell injection at week 6 - 2 weeks and then as clinically needed After the disease re-evaluation if the patients disease has not gotten worse or if in the future it seems heshe might benefit they may be eligible to receive one additional dose of the T cells The dose will be at the same dose level as the patients first infusion and separated by at least 6 weeks such that the investigators can make sure that the patient has no severe side effects between infusions If the patient receives an additional dose of C7R EBV T-cells they will need to stay in Houston for up to 2 weeks after the infusion as well so the investigators can monitor them for side effects
Medical tests before treatment--
Before being treated the patient will receive a series of standard medical tests
Physical exam
Blood tests to measure blood cells kidney and liver function
Measurements of the tumor by routine imaging studies The investigators will use the imaging studies that have been used in the past to best assess the patients tumor Computer Tomogram CT or Magnetic Resonance Imaging MRI and Positron Emission Tomography PETCT andor Bone Scan
Medical tests during and after treatment--
The patient will receive standard medical tests when they are getting the infusions and afterwards
Physical exams
Blood tests to measure blood cells kidney and liver function
Measurements of the tumor by routine imaging studies approximately 6 weeks after the infusion
To learn more about the way the C7R EBV T cells are working and how long they last in the body an extra amount of blood will be obtained on the day that chemotherapy starts the day of the T-cell infusions and at the end of the T-cell infusions 1 2 4 6 weeks after the T-cell infusions and every 3 months for the 1st year and annually for the next 15 years and possibly at additional time points The amount of blood taken will be based on the patients weight with up to a maximum of 60 mL 12 teaspoons of blood to be obtained at any one time For children the total amount of blood drawn will not be more than 3 mL less than 1 teaspoon per 1 kg 2 lbs of body weight on any one day This volume is considered safe but may be decreased if the patient is anemic have a low red blood cell count
If the patient has a procedure where tumor samples are obtained like a repeat bone marrow evaluation or tumor biopsy the investigators request a sample to be used for research purposes Patients will receive supportive care for any acute or chronic toxicities including blood components or antibiotics and other intervention as appropriate
When they are enrolled in this study patients are assigned a dose of C7R EBV T cells The assigned dose of cells is based on body weight and height Patients will receive the C7R EBV T cells and may also receive cyclophosphamide and fludarabine these are standard chemotherapy medicines The chemotherapy medicines may be given before the T cells to make space in the blood for the T cells to grow after receiving them
If a patient receives chemotherapy medicines these drugs will be given through an iv needle inserted in the patients vein or central line for 2 days and then fludarabine alone on the third day The patient will be given an injection of C7R EBV T cells into the vein through an IV line at the assigned dose
Patients may receive Benadryl and Tylenol The infusion will take between 1 and 10 minutes The investigators will then monitor the patient in the clinic or hospital for about 2 hours The treatment will be given by the Center for Cell and Gene Therapy at Texas Childrens Hospital or Houston Methodist Hospital Patients should plan to stay in Houston for up to 2 weeks after the infusion so the investigators can monitor them for side effects
Patients will have follow-up visits with the clinic at scheduled visits weeks 2 and 6 and nursing follow-up at weeks 1 2 4 and 6 months 3 6 9 and 12 and annually for the next 15 years Patients will have scheduled disease evaluations after the T-cell injection at week 6 - 2 weeks and then as clinically needed After the disease re-evaluation if the patients disease has not gotten worse or if in the future it seems heshe might benefit they may be eligible to receive one additional dose of the T cells The dose will be at the same dose level as the patients first infusion and separated by at least 6 weeks such that the investigators can make sure that the patient has no severe side effects between infusions If the patient receives an additional dose of C7R EBV T-cells they will need to stay in Houston for up to 2 weeks after the infusion as well so the investigators can monitor them for side effects
Medical tests before treatment--
Before being treated the patient will receive a series of standard medical tests
Physical exam
Blood tests to measure blood cells kidney and liver function
Measurements of the tumor by routine imaging studies The investigators will use the imaging studies that have been used in the past to best assess the patients tumor Computer Tomogram CT or Magnetic Resonance Imaging MRI and Positron Emission Tomography PETCT andor Bone Scan
Medical tests during and after treatment--
The patient will receive standard medical tests when they are getting the infusions and afterwards
Physical exams
Blood tests to measure blood cells kidney and liver function
Measurements of the tumor by routine imaging studies approximately 6 weeks after the infusion
To learn more about the way the C7R EBV T cells are working and how long they last in the body an extra amount of blood will be obtained on the day that chemotherapy starts the day of the T-cell infusions and at the end of the T-cell infusions 1 2 4 6 weeks after the T-cell infusions and every 3 months for the 1st year and annually for the next 15 years and possibly at additional time points The amount of blood taken will be based on the patients weight with up to a maximum of 60 mL 12 teaspoons of blood to be obtained at any one time For children the total amount of blood drawn will not be more than 3 mL less than 1 teaspoon per 1 kg 2 lbs of body weight on any one day This volume is considered safe but may be decreased if the patient is anemic have a low red blood cell count
If the patient has a procedure where tumor samples are obtained like a repeat bone marrow evaluation or tumor biopsy the investigators request a sample to be used for research purposes Patients will receive supportive care for any acute or chronic toxicities including blood components or antibiotics and other intervention as appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None