T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
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|ClinicalTrials.gov Identifier: NCT02659943|
Recruitment Status : Active, not recruiting
First Posted : January 21, 2016
Last Update Posted : December 19, 2020
The immune system fights infection and can affect cancer cells. T cells are white blood cells that are a major part of the immune system. T cells can destroy tumors. Researchers want to try to manipulate the immune system to better recognize and kill tumor cells.
To test the safety of giving T cells expressing a novel fully-human anti-CD19 chimeric antigen receptor (CAR) to people with advanced B-cell cancer.
People ages 18 73 with a B-cell cancer that has not been controlled by other therapies.
Participants will be screened with:
Blood and urine tests
Bone marrow sample taken
Scans in machines that take pictures
Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm.
The cells will be changed in a laboratory.
Participants will get 2 chemotherapy drugs over 3 days.
Two days later, participants will check into the hospital. They will get an intravenous (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion.
After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.
Participants will have visits 6 visits for 1 year after the infusion. Some may have more follow-up visits.
Participants may samples taken of spinal fluid, bone marrow, and tumors.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, B-Cell Lymphoma, Non-hodgkins||Biological: Anti-CD19-CAR T cells Drug: Cyclophosphamide Drug: Fludarabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||T Cells Expressing a Fully-Human Anti-CD19 Chimeric Antigen Receptor for Treating B-cell Malignancies|
|Actual Study Start Date :||January 21, 2016|
|Actual Primary Completion Date :||June 12, 2018|
|Estimated Study Completion Date :||December 31, 2022|
Dose escalation for patients who never had an alloHSCT
Biological: Anti-CD19-CAR T cells
Dose-escalation trial starting dose: 0.66x106 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0
300 mg/m2 IV infusion over 30 minutes on days -5, -4 and -3
30 mg/m2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3
- Determine the safety and feasibility of administering T cells expressing a novel fully-human anti-CD19 chimeric antigen receptor (CAR) [ Time Frame: 4-5 weeks after first dose ]List of adverse event frequency
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659943
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||James N Kochenderfer, M.D.||National Cancer Institute (NCI)|