Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02215967|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : November 21, 2018
- T cells are white blood cells that fight several cancers. One cancer therapy involves removing a person s T cells, changing them in a lab, and then returning them to the person. Researchers want to see if this helps people with multiple myeloma.
- To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with multiple myeloma.
- Adults ages 18 70 with multiple myeloma that has not responded to standard therapies.
- Participants may be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Heart tests
- Bone marrow sample
- Multiple scans and X-rays
- 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 visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion, then every 6 months. A bone marrow sample will be taken at the 2-month visit.
- Participants blood will be collected for several years. Participants will have an annual physical at NIH for 5 years after the infusion. Then for 10 years they will answer health questionnaires.
|Condition or disease||Intervention/treatment||Phase|
|Myeloma, Plasma-Cell Myeloma-Multiple||Drug: Cyclophosphamide Drug: Fludarabine Biological: Anti-BCMA CAR T cells||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma|
|Study Start Date :||August 12, 2014|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Dose Escalation with 5 dose levels based on the patients actual bodyweight
300 mg/m2 IV over 30 minutes on days -5, -4, and -3
30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3
Biological: Anti-BCMA CAR T cells
0.3x106- 15.0x106 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- Determine the safety of administering T cells expressing an BCMA CAR [ Time Frame: 2 weeks-12 months after initial 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): NCT02215967
|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)|