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Clinical Trial Summary

The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-SLAMF7 bispecific antibody armed activated T cells (SLAMF7 BATs/CS1 BATs) for patients with relapsed and/or refractory multiple myeloma. Patients receive 4 weekly doses and then 4 more doses every 2 weeks of SLAMF7 BATs by intravenous infusion. If patients have at least stable disease after these infusions, then they may receive additional infusions every 4 weeks up to a maximum of 21 infusions (including the initial 8 infusions).


Clinical Trial Description

Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure at approximately 3 to 4 weeks prior to the first SLAMF7 BATs infusion. The white blood cells, specifically T cells, are then mixed with two proteins, OKT3 and IL-2, which activate the cells to multiply. After approximately 14 days in culture, the activated T cells are coated with the OKT3 and elotuzumab (an anti-SLAMF7 drug) to produce bispecific antibody armed T cells (BATs). Cells are then frozen and stored until scheduled to be infused. About 4 weeks after the leukapheresis procedure, SLAMF7 BATs infusions will start. At week 10 of SLAMF7 BATs infusions, disease status will be checked and patients who have stable disease or better may be eligible for additional SLAMF7 BATs infusions about every 4 weeks. Before, throughout and following SLAMF7 BATs, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04864522
Study type Interventional
Source University of Virginia
Contact Ioannis Vassalos, MD
Phone 434-924-9496
Email [email protected]
Status Not yet recruiting
Phase Early Phase 1
Start date May 15, 2021
Completion date January 1, 2027

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