Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06176690
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
Constitutive IL7R C7R Modified Banked Allogeneic CD30CAR EBVSTS for CD30-Positive Lymphomas
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Constitutive IL7R C7R Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes CD30CAR-EBVSTs in Patients with Relapsed or Refractory CD30-Positive Lymphomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves patients that have a cancer called diffuse large B cell lymphoma DLBCL Natural killerT-cell lymphoma NKTL or classical Hodgkin lymphoma cHL hereafter referred to collectively as lymphoma Patients lymphoma has come back or not gone away after treatment
A previous research study conducted at Baylor combined two ways of fighting disease antibodies and T cells Antibodies are proteins that bind to bacteria viruses and other foreign substances to prevent them causing disease T-cells are special infection-fighting white blood cells that can kill tumor cells or cells infected with bacteria and viruses Both have shown promise treating cancer but neither has been strong enough to cure most patients In the previous study an antibody called anti-CD30 which is found on the surface of some T-cells and cancer cells and had been used to treat lymphoma with limited success was joined to the T-cells through a process called gene transfer resulting in CD30CAR T cells
Another study saw encouraging responses using CD30CAR T cells made in a lab from a patients own blood before being injected back into the same patient to treat their lymphoma These cells are termed autologous because they are given back to the original patient In another ongoing study patients were treated with allogeneic CD30CAR T cells which are made from healthy donors instead of the patients The use of allogenic cells avoids a lengthy manufacture time since the products are stored as a bank and available on demand This ongoing trial of allogeneic banked CD30CAR-EBVSTs has preliminarily shown promising clinical activity with no safety concerns
With the current study investigators plan to extend the anti-cancer effects of the CD30CAR T cell by attaching another molecule called C7R which has made CAR T cells have deeper and longer anticancer effects in laboratory studies The aim is to study the safety and effectiveness of allogeneic banked CD30CAR-EBVST cells that also carry the C7R molecule Investigators will learn the side effects of C7R modified CD30CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients
A previous research study conducted at Baylor combined two ways of fighting disease antibodies and T cells Antibodies are proteins that bind to bacteria viruses and other foreign substances to prevent them causing disease T-cells are special infection-fighting white blood cells that can kill tumor cells or cells infected with bacteria and viruses Both have shown promise treating cancer but neither has been strong enough to cure most patients In the previous study an antibody called anti-CD30 which is found on the surface of some T-cells and cancer cells and had been used to treat lymphoma with limited success was joined to the T-cells through a process called gene transfer resulting in CD30CAR T cells
Another study saw encouraging responses using CD30CAR T cells made in a lab from a patients own blood before being injected back into the same patient to treat their lymphoma These cells are termed autologous because they are given back to the original patient In another ongoing study patients were treated with allogeneic CD30CAR T cells which are made from healthy donors instead of the patients The use of allogenic cells avoids a lengthy manufacture time since the products are stored as a bank and available on demand This ongoing trial of allogeneic banked CD30CAR-EBVSTs has preliminarily shown promising clinical activity with no safety concerns
With the current study investigators plan to extend the anti-cancer effects of the CD30CAR T cell by attaching another molecule called C7R which has made CAR T cells have deeper and longer anticancer effects in laboratory studies The aim is to study the safety and effectiveness of allogeneic banked CD30CAR-EBVST cells that also carry the C7R molecule Investigators will learn the side effects of C7R modified CD30CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients
Detailed Description:
This is a dose escalation study This means that at the beginning patients will be started on the lowest dose 1 of 4 different levels of C7RCD30CAR-EBVST cells Once the lower dose schedule proves safe the next group of patients will be started at a higher dose This process will continue until all 4 dose levels are studied If the side effects are too severe the dose will be lowered or the T cell infusion will be stopped Both the risks and benefits of this study may be dose related The investigators dont know the best dose that will provide benefit while minimizing the risks
To enroll on this study patients will need to have recovered from toxic effects of previous chemotherapy and not be receiving any other investigational agents Patients cannot have received an investigational cell therapy or vaccine within the past 6 weeks Patients cannot have received an investigational small molecule drug within the past 2 weeks
If patients agree to take part in this study the investigators will ask the patients to adhere to the following study visits and procedure After patients have signed the consent form patients are required to come to the hospital for a series of standard medical screening tests lymphodepletion chemotherapy infusion with CD30CAR-EBVST cell treatment and follow-up visits See details below
1 Screening tests Screening tests include
Blood tests Human Leukocyte Antigen HLA testing to help us identify the best match for patients from the banked CD30CAR- EBVST cells
Blood tests for viruses such as human immunodeficiency virus HIV human T cell lymphotropic virus HTLV hepatitis B virus and hepatitis C virus
Tumor biopsy test to check the status of CD30
Once the investigators find that patients are eligible for this study patients will be called for additional screening tests before treatment day The screening tests include
Physical examination
Vital signs tests to measure temperature pulse respiratory rate and blood pressure
Blood tests to measure blood cells kidney and liver functions
Urine test
Pregnancy test for women of child-bearing potential
Measurements of tumor by routine imaging studies
2 Lymphodepletion chemotherapy Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions and that this may not happen if there are too many other T cells in the blood stream Because of that if patients have NOT had a bone marrow or stem cell transplant recently patients will receive treatment with cyclophosphamide and fludarabine chemotherapy drugs before patients receive the C7RCD30CAR-EBVST cells if patients doctor thinks this is appropriate This is called lymphodepletion
These drugs will decrease the numbers of patients own T cells before the investigators inject the C7RCD30CAR-EBVST cells Although the investigators do not expect any effect on the patients tumor with the dose that the patients will receive these drugs are part of many regimens that are used to treat lymphoma
3 Treatment with C7RCD30CAR-EBVST cells
Each patient will receive a total dose of CAR modified T cells as detailed below Dose level cohorts will be numbered sequentially
Dose Level 1 4 107 C7RCD30CAR-EBVST cells
Dose Level 2 1 108 C7RCD30CAR-EBVST cells
Dose Level 3 4 108 C7RCD30CAR-EBVST cells
Dose Level 4 8 108 C7RCD30CAR-EBVST cells
The C7RCD30CAR-EBVST cells will be infused via an IV line at the indicated dose Before patients receive the infusion they may be given a dose of acetaminophen or anti-histamine Benadryl for example to minimize any possible allergic reaction The investigators will follow patients in the clinic after each infusion for up to 3 hours The patient will need to stay less than 2 hours away from the Medical Center for 4 weeks after the C7RCD30CAR-EBVST cell infusion so the investigator can monitor them for side effects
4 Follow-up visits
On follow-up visits after treatment patients will also receive a series of standard medical tests
Physical examination
Vital sign tests to measure temperature pulse respiratory rate and blood pressure
Blood tests to measure blood cells kidney and liver functions
Urine tests if clinically necessary
Pregnancy test for women of child-bearing potential if clinically necessary
Measurements of tumor by routine imaging studies
After infusion of C7RCD30CAR-EBVST cellsthe patients blood will be collected on follow-up visits at week 1 week 2 week 3 week 4 week 6 week 8 every 3 months for 1 year every 6 months for 4 more years After 15 years in the event there is suspected or new cancer is detected additional blood sample will also be collected for additional tests
To learn more about the way the C7RCD30CAR-EBVST cells are working and how long they last in the body the investigators will draw blood from a central line if participants have one
The investigators will also look at any scans or biopsies patients have had as standard of care
To enroll on this study patients will need to have recovered from toxic effects of previous chemotherapy and not be receiving any other investigational agents Patients cannot have received an investigational cell therapy or vaccine within the past 6 weeks Patients cannot have received an investigational small molecule drug within the past 2 weeks
If patients agree to take part in this study the investigators will ask the patients to adhere to the following study visits and procedure After patients have signed the consent form patients are required to come to the hospital for a series of standard medical screening tests lymphodepletion chemotherapy infusion with CD30CAR-EBVST cell treatment and follow-up visits See details below
1 Screening tests Screening tests include
Blood tests Human Leukocyte Antigen HLA testing to help us identify the best match for patients from the banked CD30CAR- EBVST cells
Blood tests for viruses such as human immunodeficiency virus HIV human T cell lymphotropic virus HTLV hepatitis B virus and hepatitis C virus
Tumor biopsy test to check the status of CD30
Once the investigators find that patients are eligible for this study patients will be called for additional screening tests before treatment day The screening tests include
Physical examination
Vital signs tests to measure temperature pulse respiratory rate and blood pressure
Blood tests to measure blood cells kidney and liver functions
Urine test
Pregnancy test for women of child-bearing potential
Measurements of tumor by routine imaging studies
2 Lymphodepletion chemotherapy Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions and that this may not happen if there are too many other T cells in the blood stream Because of that if patients have NOT had a bone marrow or stem cell transplant recently patients will receive treatment with cyclophosphamide and fludarabine chemotherapy drugs before patients receive the C7RCD30CAR-EBVST cells if patients doctor thinks this is appropriate This is called lymphodepletion
These drugs will decrease the numbers of patients own T cells before the investigators inject the C7RCD30CAR-EBVST cells Although the investigators do not expect any effect on the patients tumor with the dose that the patients will receive these drugs are part of many regimens that are used to treat lymphoma
3 Treatment with C7RCD30CAR-EBVST cells
Each patient will receive a total dose of CAR modified T cells as detailed below Dose level cohorts will be numbered sequentially
Dose Level 1 4 107 C7RCD30CAR-EBVST cells
Dose Level 2 1 108 C7RCD30CAR-EBVST cells
Dose Level 3 4 108 C7RCD30CAR-EBVST cells
Dose Level 4 8 108 C7RCD30CAR-EBVST cells
The C7RCD30CAR-EBVST cells will be infused via an IV line at the indicated dose Before patients receive the infusion they may be given a dose of acetaminophen or anti-histamine Benadryl for example to minimize any possible allergic reaction The investigators will follow patients in the clinic after each infusion for up to 3 hours The patient will need to stay less than 2 hours away from the Medical Center for 4 weeks after the C7RCD30CAR-EBVST cell infusion so the investigator can monitor them for side effects
4 Follow-up visits
On follow-up visits after treatment patients will also receive a series of standard medical tests
Physical examination
Vital sign tests to measure temperature pulse respiratory rate and blood pressure
Blood tests to measure blood cells kidney and liver functions
Urine tests if clinically necessary
Pregnancy test for women of child-bearing potential if clinically necessary
Measurements of tumor by routine imaging studies
After infusion of C7RCD30CAR-EBVST cellsthe patients blood will be collected on follow-up visits at week 1 week 2 week 3 week 4 week 6 week 8 every 3 months for 1 year every 6 months for 4 more years After 15 years in the event there is suspected or new cancer is detected additional blood sample will also be collected for additional tests
To learn more about the way the C7RCD30CAR-EBVST cells are working and how long they last in the body the investigators will draw blood from a central line if participants have one
The investigators will also look at any scans or biopsies patients have had as standard of care
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?:
None
Is an FDA AA801 Violation?:
None