Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02475707
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2015-06-12
Brief Title:
Administration of Donor MultiTAA-Specific T Cells for ALL
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Administration of Donor-Derived Multi-Tumor-Associated Antigen TAA-Specific T Cells to Patients With ALL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
STELLA
Brief Summary:
This study uses special blood cells called multiple tumor-associated antigen TAA-specific T cells to treat patients with acute lymphoblastic leukemia ALL which has come back or may come back or has not gone away after standard treatment including an allogeneic hematopoietic stem cell transplant HSCT
The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphomas that are infected with Epstein-Barr virus EBV EBV is found in cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma This suggests that it may play a role in causing lymphoma The cancer cells infected by EBV are able to hide from the bodys immune system and escape being killed The investigators previously tested whether special white blood cells called T cells that were trained to kill EBV-infected cells could affect these tumors and in many patients the investigators found that giving these trained T cells caused a complete or partial response
Other cancers express specific proteins that can be targeted in the same way The investigators have been able to infuse such tumor-targeted cells into up to 10 patients with lymphoma who do not have EBV and seen some complete responses Importantly the treatment appears to be safe Therefore the investigators now want to test whether the investigators can direct these special T cells against other types of cancers that carry similar proteins called tumor-associated antigens TAAs These proteins are specific to the leukemia cell so they either do not show up or show up in low quantities on normal human cells
The investigators will grow T cells from patients stem cell donors in the laboratory in a way that will train them to recognize the tumor proteins WT1 PRAME and Survivin which are expressed on most ALL cancer cells The cells will be infused at least 30 days post-allogeneic HSCT In this study the investigators want to see whether these cells will be able to recognize and kill leukemia cells that express these antigens These donor-derived multiTAA-specific T cells are an investigational product not yet approved by the US Food and Drug Administration
The purpose of this study is to find the largest safe dose of donor-derived multiTAA-specific T cells for patients with ALL
The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphomas that are infected with Epstein-Barr virus EBV EBV is found in cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma This suggests that it may play a role in causing lymphoma The cancer cells infected by EBV are able to hide from the bodys immune system and escape being killed The investigators previously tested whether special white blood cells called T cells that were trained to kill EBV-infected cells could affect these tumors and in many patients the investigators found that giving these trained T cells caused a complete or partial response
Other cancers express specific proteins that can be targeted in the same way The investigators have been able to infuse such tumor-targeted cells into up to 10 patients with lymphoma who do not have EBV and seen some complete responses Importantly the treatment appears to be safe Therefore the investigators now want to test whether the investigators can direct these special T cells against other types of cancers that carry similar proteins called tumor-associated antigens TAAs These proteins are specific to the leukemia cell so they either do not show up or show up in low quantities on normal human cells
The investigators will grow T cells from patients stem cell donors in the laboratory in a way that will train them to recognize the tumor proteins WT1 PRAME and Survivin which are expressed on most ALL cancer cells The cells will be infused at least 30 days post-allogeneic HSCT In this study the investigators want to see whether these cells will be able to recognize and kill leukemia cells that express these antigens These donor-derived multiTAA-specific T cells are an investigational product not yet approved by the US Food and Drug Administration
The purpose of this study is to find the largest safe dose of donor-derived multiTAA-specific T cells for patients with ALL
Detailed Description:
To make donor-derived multiTAA-specific T cells the investigators will collect blood from the patients stem cell donor and mix the donors T cells with small pieces of the tumor proteins WT1 PRAME and Survivin These protein fragments stimulate the donor T cells to grow and react against these proteins in such a way that they will recognize and kill cancer cells that express these proteins Once sufficient numbers of multiTAA-specific T cells have been made the investigators test them to make sure they target the patients cancer cells but not their normal healthy cells
The multiTAA-specific T cells will be administered as a single intravenous IV infusion over 10 minutes The patients cancer will be assessed within 4 weeks prior to the T cell infusion at 4-6 weeks and again at 8-12 weeks after the infusion If at least 4 weeks after the infusion there is no change or a reduction in the number of cancer cells measured in the bone marrow or a decline in cancer-specific markers in the blood patients may receive up to six 6 additional doses of the T cells at least 4 weeks apart All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Childrens Hospital
For at least 4 weeks after the infusion patients may not receive any other anti-cancer treatments such as radiation therapy or chemotherapy with the exception of drugs like dasatinib Patients who do receive any other therapies will be taken off treatment and will not be able to receive additional doses of T cells
This is a dose escalation study which means that at the beginning patients will be started on the lowest dose 1 of 3 different levels of T cells Once that dose level proves safe the next group of patients will be started at the next highest dose This process will continue until all 3 dose levels have been studied If side-effects are too severe the dose will be lowered or the T cell injections will be stopped
Before being treated patients will undergo a series of standard medical tests
Physical exam
Blood tests to measure blood cells kidney and liver function
Measurement of ALL done by a bone marrow biopsy or blood tests
Pregnancy test if patient is a female who can have children
Patients will undergo standard medical tests both during the T cell infusions and after
Blood tests to measure blood cells kidney and liver function
Measurement of disease 4-6 weeks and 8-12 weeks after the T cell infusion done by bone marrow biopsy or blood tests
Active participation in this study will last for approximately one 1 year If the patient receives additional doses of the T cells as described above their active participation will last until one 1 year after the last dose of T cells We will then contact the patient once a year for up to 4 additional years total of 5 years follow-up in order to evaluate disease response long-term
The multiTAA-specific T cells will be administered as a single intravenous IV infusion over 10 minutes The patients cancer will be assessed within 4 weeks prior to the T cell infusion at 4-6 weeks and again at 8-12 weeks after the infusion If at least 4 weeks after the infusion there is no change or a reduction in the number of cancer cells measured in the bone marrow or a decline in cancer-specific markers in the blood patients may receive up to six 6 additional doses of the T cells at least 4 weeks apart All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Childrens Hospital
For at least 4 weeks after the infusion patients may not receive any other anti-cancer treatments such as radiation therapy or chemotherapy with the exception of drugs like dasatinib Patients who do receive any other therapies will be taken off treatment and will not be able to receive additional doses of T cells
This is a dose escalation study which means that at the beginning patients will be started on the lowest dose 1 of 3 different levels of T cells Once that dose level proves safe the next group of patients will be started at the next highest dose This process will continue until all 3 dose levels have been studied If side-effects are too severe the dose will be lowered or the T cell injections will be stopped
Before being treated patients will undergo a series of standard medical tests
Physical exam
Blood tests to measure blood cells kidney and liver function
Measurement of ALL done by a bone marrow biopsy or blood tests
Pregnancy test if patient is a female who can have children
Patients will undergo standard medical tests both during the T cell infusions and after
Blood tests to measure blood cells kidney and liver function
Measurement of disease 4-6 weeks and 8-12 weeks after the T cell infusion done by bone marrow biopsy or blood tests
Active participation in this study will last for approximately one 1 year If the patient receives additional doses of the T cells as described above their active participation will last until one 1 year after the last dose of T cells We will then contact the patient once a year for up to 4 additional years total of 5 years follow-up in order to evaluate disease response long-term
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STELLA | OTHER | Baylor College of Medicine | None |