Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma
- Cancer development is associated with problems in immune system functions, which prevent the body from attacking and destroying the abnormal cells that lead to tumor growth. Research has suggested that certain white blood cells, known as Th1 and Th2 T cells, are affected in individuals with some kinds of cancer -- when the proportion of Th2 cells is greater than Th1 cells, the immune system s ability to fight off the growth of malignant tumors is weakened. Researchers are interested in determining if an infusion of specially modified Th1 cells, in addition to stem cell transplant, is a safe and effective treatment for individuals with forms of multiple myeloma that might not respond well to standard treatments alone.
- To determine the safety and effectiveness of the infusion of modified Th1 white blood cells, in conjunction with standard treatment, as a treatment for individuals who have been diagnosed with high-risk forms of multiple myeloma.
- Individuals age 18 to 75 who have been newly diagnosed with high-risk multiple myeloma and who have received no or minimal treatment (4 months or less) yet..
- Participants will be screened with a medical history, physical examination, blood and urine tests, and imaging studies. Some participants may also have a bone marrow or other type biopsy to evaluate the state of their disease.
- White blood cells will be collected from the participants through an apheresis procedure, which will collect and separate the white blood cells and return the rest of the blood to the participant.
- The collected cells will be grown and expanded under special conditions in the laboratory and stored frozen until participants receive all the standard of care treatment for multiple myeloma, including a stem cell transplant.
- Participants will receive an infusion of the modified Th1 cells a few weeks after the transplant, and will remain in the hospital for a few days after receiving the cells to monitor the possible immediate effects of the treatment.
- Participants will have regular follow-up visits to study the long-term effects of the modified Th1 cell infusion.
Procedure: Adoptive Immunotherapy
Drug: Th1/Tc1 product
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-Center Phase I Study of Th1/Tc1 Immunotheraphy Following Autologous Hematopoietic Progenitor Cell Transplantation in High Risk Multiple Myeloma|
- Evaluate the feasibility and toxicity of an infusion of autologous, ex vivo rapamycin-generated, anti-CD3 and anti-CD28 co-stimulated, Th1/Tc1 lymphocytes (Th1.rapa cells) in subjects newly diagnosed with high-risk multiple myeloma. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Overall Survival [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Procedure: Adoptive Immunotherapy
N/ADrug: Th1/Tc1 product
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239368
|Contact: Daniel H Fowler, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|United States, New Jersey|
|Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States|
|Principal Investigator:||Daniel H Fowler, M.D.||National Cancer Institute (NCI)|