Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078520
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2004-03-01
Brief Title:
Treatment of B-CLL With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Treatment of Chronic Lymphocytic B-Leukemia B-CLL With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells CLIPA
Status:
COMPLETED
Status Verified Date:
2020-01
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:
CLIPA
Brief Summary:
This study is for patients that have chronic lymphocytic leukemia CLL This research study aims to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer
To do this we will put a special gene into cancer cells that have been taken from the patients body This will be done in the laboratory This gene will make the cells produce interleukin 2 IL-2 which is a natural substance that may help the immune system kill cancer cells Additionally we will stimulate the cancer cells with another natural protein called CD40 ligand CD40L which experiments in animal and human cells in vitro demonstrated can help IL-2 perform better
Some of these cells will then be put back into the patients body Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells An experimental treatment similar to this has already been used in children and similar experimental treatments are being used in adults with other cancers
To do this we will put a special gene into cancer cells that have been taken from the patients body This will be done in the laboratory This gene will make the cells produce interleukin 2 IL-2 which is a natural substance that may help the immune system kill cancer cells Additionally we will stimulate the cancer cells with another natural protein called CD40 ligand CD40L which experiments in animal and human cells in vitro demonstrated can help IL-2 perform better
Some of these cells will then be put back into the patients body Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells An experimental treatment similar to this has already been used in children and similar experimental treatments are being used in adults with other cancers
Detailed Description:
This is a phase I trial to assess the safety of a dose escalation of hCD40L-expressing autologous tumor cells with a fixed dose of recombinant hIL-2 gene transduced autologous leukemic blasts All eligible patients will be treated with a minimum of three and up to six injections There will be no use of placebo or control subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| CLIPA | None | None | None |