Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT06185751
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Relapsed or refractory multiple myeloma after 3 or more prior lines of therapy,<br> including proteasome inhibitor (e.g. bortezomib or carfilzomib), anti-CD38 therapy<br> (e.g. daratumumab), and anti-BCMA therapies (e.g. BCMA bispecific antibodies or BCMA<br> CAR-T)<br><br> - Measurable disease, defined as meeting at least one of the following criteria:<br><br> - Serum M-protein = 0.5 g/dL<br><br> - Urine M-protein = 200 mg/24 h<br><br> - Serum FLC assay: involved FLC level =10 mg/dL (100 mg/L) with abnormal serum<br> FLC ratio<br><br> - A biopsy-proven plasmacytoma<br><br> - Bone marrow plasma cells > 30% of total bone marrow cells<br><br> - At least 18 years of age.<br><br> - ECOG performance status = 1<br><br> - Adequate renal, hepatic, respiratory, and cardiovascular function, as defined below:<br><br> - Renal function:<br><br> - calculated creatinine clearance = 50 mL/min/1.73 m2 OR<br><br> - radioisotope glomerular filtration rate = 50 mL/min/1.73 m2 OR<br><br> - normal serum creatinine based on age/gender per institutional normal range<br><br> - Hepatic function:<br><br> - ALT (SGPT) = 5 x ULN for age<br><br> - Total bilirubin = 2.0 x IULN (unless the patient has Grade 1 bilirubin<br> elevation due to Gilbert's disease or a similar syndrome involving slow<br> conjugation of bilirubin)<br><br> - Respiratory function:<br><br> - Minimum level of pulmonary reserve defined as oxygen saturation > 91%<br> measured by pulse oximetry on room air<br><br> - Cardiovascular function:<br><br> - LVEF = 45% confirmed by echocardiogram or MUGA within 28 days of screening<br><br> - The effects of CS1 CAR-T on the developing human fetus are unknown. For this reason,<br> women of childbearing potential and men must agree to use adequate contraception (at<br> least 2 forms of contraception, including one barrier method) prior to study entry<br> and for 12 months after CS1 CAR-T infusion. If a female subject or female partner of<br> a male subject becomes pregnant during therapy or within 12 months following<br> WS-CART-CS1 infusion, the investigator must be notified in order to facilitate<br> outcome follow-up.<br><br> - Ability to understand and willingness to sign an IRB-approved written informed<br> consent document (or that of legally authorized representative, if applicable).<br><br>Exclusion Criteria:<br><br> - Any prior systemic therapy for multiple myeloma within 14 days before planned day of<br> leukapheresis.<br><br> - A history of other malignancy with the exception of treated non-melanomatous skin<br> cancers and malignancies for which all treatment was completed at least 2 years<br> before registration and the subject has no evidence of disease.<br><br> - Currently receiving any other investigational agents.<br><br> - Receipt of any cellular therapy within 8 weeks prior to the planned start of<br> conditioning.<br><br> - A history of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to CS1 CAR-T or other agents used in the study.<br><br> - History of Grade 3 CRS or ICANS with other CAR-Ts (including BCMA CAR).<br><br> - Active hepatitis B, active hepatitis C, any uncontrolled infection, or HIV<br> infection.<br><br> - Ongoing or active infection or other serious underlying medical condition that would<br> impair the ability to receive protocol treatment.<br><br> - Pregnant and/or breastfeeding. Women of childbearing potential must have a negative<br> pregnancy test within 14 days of study entry.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A: Frequency and severity of treatment-emergent adverse events;Part A: Frequency of dose-limiting toxicities (DLTs);Part B: Frequency and severity of treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method Part A MTD and Part B: Disease-specific objective response rate (ORR);Part A MTD and Part B: Minimal residual disease (MRD) negativity in the marrow;Part A MTD and Part B: Duration of response (DoR);Part A MTD and Part B: Progression-free survival (PFS);Part A MTD and Part B: Overall survival (OS)