Pilot Study of SLAMF7 BATs/CS-1 BATs in Relapsed/Refractory Multiple Myeloma (MM BATs)
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|ClinicalTrials.gov Identifier: NCT04864522|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: SLAMF7 BATs||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||SLAMF7 BATs|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Anti-CD3 x Anti-SLAMF7 (Anti-CS-1) Bispecific Antibody Armed Activated T-Cells (SLAMF7 BATs/CS-1 BATs) in Relapsed/Refractory Multiple Myeloma|
|Estimated Study Start Date :||May 15, 2021|
|Estimated Primary Completion Date :||January 1, 2026|
|Estimated Study Completion Date :||January 1, 2027|
Experimental: SLAMF7 BATs
Participants will undergo apheresis to collect cells to make SLAMF7 BATs. These cells will be allowed to grow in the lab and a drug will be added to them to make them activated against multiple myeloma. About 4 weeks after apheresis, participants will start receiving SLAMF7 BATs. Throughout treatment, participants will have blood taken for labs, to check disease status and also to look at immune response. Study treatment will stop if the participant has disease progression.
Drug: SLAMF7 BATs
Participants will receive 4 weekly infusions of SLAMF7 BATs, then 4 infusions every 2 weeks. Participants that have stable disease or better at week 10 of treatment may continue to receive an infusions every 4 weeks for up to a total of 21 infusions (including the first 8).
Other Name: CS-1 BATs
- Unacceptable adverse events (UAEs) [ Time Frame: From time of informed consent through 30 days following last BATs infusion ]An adverse event that is considered at least possibly related to SLAMF7 BATs and meets at least one of the protocol-defined criteria
- Progression-free survival (PFS) [ Time Frame: From informed consent through first progression or 1 year after enrollment ]Duration of time from consent through first progression (or end of follow-up)
- Overall response rate (ORR) [ Time Frame: About 4 weeks following 8th BATs infusion ]As defined by International Myeloma Working Group (IMWG) response criteria (partial response (PR), very good partial response (VGPR), complete response (CR), stringent CR (sCR)
- Adverse event profile [ Time Frame: From time of informed consent through 30 days following last BATs infusion ]Severity, frequency, category, seriousness and duration of adverse events
- Minimal Residual Disease (MRD) status [ Time Frame: About 4 weeks following 8th BATs infusion ]Assessed by ClonoSeq, only for patients who achieve stringent CR
- Overall Survival (OS) [ Time Frame: Through 12 months after last BATs infusion ]Duration of time from consent through death or 12 months after last BATs infusion
- Number of IFNgamma secreting cells [ Time Frame: Multiple timepoints through 12 months after last BATs infusion ]As measured by Elispots
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): NCT04864522
|Contact: Ioannis Vassalos, MDfirstname.lastname@example.org|
|Contact: Jungeun Kim, PhDemail@example.com|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Contact: Ioannis Vassalos, MD 434-924-9496 firstname.lastname@example.org|
|Contact: Jungeun Kim, PhD 434-982-3365 email@example.com|
|Principal Investigator: Laahn Foster, MD|
|Principal Investigator:||Laahn Foster, MD||University of Virginia|