Multiple MyelomaPhase 1NCT06185751
Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma
A Phase 1 study testing WS-CART-CS1 and Lymphodepleting chemotherapy in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Despite recent therapeutic advances, multiple myeloma (MM) remains an incurable disease. Although survival has improved, there are nevertheless diminishing durations of response to each subsequent line of therapy. This highlights the need for further therapeutic innovation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- WS-CART-CS1 and Lymphodepleting chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2024to 31 Aug 2040
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory multiple myeloma after 3 or more prior lines of therapy, including proteasome inhibitor (e.g. bortezomib or carfilzomib), anti-CD38 therapy (e.g. daratumumab), and anti-BCMA therapies (e.g. BCMA bispecific antibodies or BCMA CAR-T)
- Measurable disease, defined as meeting at least one of the following criteria:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 h
- In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels (absolute increase) must be >10 mg/dL for consideration of defining progression before enrollment
- A biopsy-proven plasmacytoma
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- Bone marrow plasma cells > 30% of total bone marrow cells
- At least 18 years of age.
- ECOG performance status ≤ 1
- Adequate renal, hepatic, respiratory, and cardiovascular function, as defined below:
- Renal function:
- calculated creatinine clearance ≥ 50 mL/min/1.73 m2 OR
- radioisotope glomerular filtration rate ≥ 50 mL/min/1.73 m2 OR
- normal serum creatinine based on age/gender per institutional normal range
- Hepatic function:
- ALT (SGPT) ≤ 5 x ULN for age
- Total bilirubin ≤ 2.0 x IULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)
- Respiratory function:
- Minimum level of pulmonary reserve defined as oxygen saturation > 91% measured by pulse oximetry on room air
- Cardiovascular function:
- LVEF ≥ 45% confirmed by echocardiogram or MUGA within 28 days of screening
- The effects of CS1 CAR-T on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (at least 2 forms of contraception, including one barrier method) prior to study entry and for 12 months after CS1 CAR-T infusion. If a female subject or female partner of a male subject becomes pregnant during therapy or within 12 months following WS-CART-CS1 infusion, the investigator must be notified in order to facilitate outcome follow-up.
- Ability to understand and willingness to sign an IRB-approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Any prior systemic therapy for multiple myeloma within 14 days before planned day of leukapheresis.
- A history of other malignancy with the exception of treated non-melanomatous skin cancers and malignancies for which all treatment was completed at least 2 years before registration and the subject has no evidence of disease.
- Currently receiving any other investigational agents.
- Receipt of any cellular therapy within 8 weeks prior to the planned start of conditioning.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CS1 CAR-T or other agents used in the study.
- History of Grade 3 CRS or ICANS with other CAR-Ts (including BCMA CAR).
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- Active hepatitis B, active hepatitis C, any uncontrolled infection, or HIV infection.
- Ongoing or active infection or other serious underlying medical condition that would impair the ability to receive protocol treatment.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Armin Ghobadi, M.D., 314-747-2743, arminghobadi@wustl.edu
Armin Ghobadi, M.D.
About this study
Official title: Phase 1 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma
Despite recent therapeutic advances, multiple myeloma (MM) remains an incurable disease. Although survival has improved, there are nevertheless diminishing durations of response to each subsequent line of therapy. This highlights the need for further therapeutic innovation. BCMA-targeting CAR-T cells show impressive response rates; however, their median duration of response is disappointing. The investigators propose that CS1(SLAMF7)-targeting CAR-T cells will fill a gap in the MM armamentarium.
CS1 is an attractive target in MM because it is expressed in most patients. Elotuzumab (Empliciti®), an approved anti-CS1 antibody, has proven the clinical efficacy of this target. CAR-T cells are an ideal modality to target CS1, given that two approved treatments, ide-cel (idecabtagene vicleucel, AbecmaTM) and cilta-cel (ciltacabtagene autoleucel, Carvykti™), have proven the potential for cellular immunotherapy in MM.
The investigators are testing the safety and preliminary anti-myeloma efficacy of WS-CART-CS1, a CAR-T cell therapy targeting CS1.
- Conditions
- Multiple Myeloma
- Being tested
- WS-CART-CS1, Lymphodepleting chemotherapy
- Keywords
- Chimeric Antigen Receptor, CS1
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WS-CART-CS1Biological
-Subject will be hospitalized for 7 days
Lymphodepleting chemotherapyDrug
- Cyclophosphamide 500 mg/m^2 IV on Days -5, -4, and -3
- Fludarabine 30 mg/m^2 IV on Days -5, -4, and -3
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation: WS-CART-CS1 | Experimental | * Undergo apheresis procedure for WS-CART-CS1 manufacturing.
* Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician.
* Lymphodepleting chemotherapy on days -5, -4, and -3.
* Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused.
* Part A is the dose escalation portion of the study. Receives: Biological: WS-CART-CS1; Drug: Lymphodepleting chemotherapy |
| Part B Dose Expansion: WS-CART-CS1 | Experimental | * Undergo apheresis procedure for WS-CART-CS1 manufacturing.
* Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician.
* Lymphodepleting chemotherapy on days -5, -4, and -3.
* Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused.
* Part B is the dose expansion portion of the study. The dose of WS-CART-CS1 will be determined in Part A of the study. Receives: Biological: WS-CART-CS1; Drug: Lymphodepleting chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Frequency and severity of treatment-emergent adverse events
- Graded by CTCAE v 5.0.
- Adverse events will be tracked at the time of leukapheresis through 28 days post leukapheresis, to capture any AEs related to leukapheresis only.
- Adverse events will then be collected beginning with lymphodepletion chemotherapy and continue through Day 100 post WS-CART-CS1 infusion or until initiation of another anticancer therapy, whichever occurs first.
- After Day 100, only targeted AEs will be reported through 24 months after WS-CART-CS1 infusion or until disease progression or relapse, whichever occurs first. Targeted AEs include and are limited to secondary malignancies, CRS, ICANS, prolonged cytopenia (defined as Grade 3 neutropenia or thrombocytopenia lasting more than 28 days after WS-CART-CS1 infusion), and SAEs or SUSARs that are not attributable to progressive disease or extraneous causes.
Measured: From leukapheresis through 24 months after WS-CART-CS1 infusion (approximately 24 months and 1 week)
Part A: Frequency of dose-limiting toxicities (DLTs)
DLTs are defined in the protocol.
Measured: From WS-CART-CS1 infusion through 28 days
Part B: Frequency and severity of treatment-emergent adverse events
- Graded by CTCAE v 5.0.
- Adverse events will be tracked at the time of leukapheresis through 28 days post leukapheresis, to capture any AEs related to leukapheresis only.
- Adverse events will then be collected beginning with lymphodepletion chemotherapy and continue through Day 100 post WS-CART-CS1 infusion or until initiation of another anticancer therapy, whichever occurs first.
- After Day 100, only targeted AEs will be reported through 24 months after WS-CART-CS1 infusion or until disease progression or relapse, whichever occurs first. Targeted AEs include and are limited to secondary malignancies, CRS, ICANS, prolonged cytopenia (defined as Grade 3 neutropenia or thrombocytopenia lasting more than 28 days after WS-CART-CS1 infusion), and SAEs or SUSARs that are not attributable to progressive disease or extraneous causes.
Measured: From leukaphereis through 24 months after WS-CART-CS1 infusion (approximately 24 months and 1 week)
Secondary outcomes (5)
Part A MTD and Part B: Disease-specific objective response rate (ORR)
-Defined as stringent complete response (sCR), plus complete response (CR), plus very good partial response (VGPR), plus partial response (PR), plus minimal response (MR) in MM within 3 months of infusion using the International Myeloma Working Group (IMWG) response criteria in MM.
Measured: Within 3 months of WS-CART-CS1 infusion
Part A MTD and Part B: Minimal residual disease (MRD) negativity in the marrow
-Based on next-generation flow (NGF), next-generation sequencing (NGS), or both
Measured: Week 12
Part A MTD and Part B: Duration of response (DoR)
-DoR for subjects who respond to treatment is measured from the time measurement criteria are met for response (whichever is first recorded) until the first date that relapse or progression is objectively documented.
Measured: -From response 24 months after WS-CART-CS1 infusion (estimated to be 24 months)
Part A MTD and Part B: Progression-free survival (PFS)
-PFS is measured from Day 0 to time of relapse, progression or death, whichever occurs first.
Measured: From WS-CART-CS1 infusion through completion of follow-up (estimated to be 15 years)
Part A MTD and Part B: Overall survival (OS)
-OS is defined as the time from start of treatment (Day 0) to time of death.
Measured: From WS-CART-CS1 infusion through completion of follow-up (estimated to be 15 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start22 Aug 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Paula C. & Rodger O. Riney Blood Cancer Research
- Responsible party
- Sponsor
- Investigators
- Armin Ghobadi, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185751
- Sponsor's protocol ID
- 202404090
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06185751
- Acronym / sponsor ID
- 202404090
- Conditions
- Multiple Myeloma
- Keywords
- Chimeric Antigen Receptor, CS1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Paula C. & Rodger O. Riney Blood Cancer Research
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2040 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite recent therapeutic advances, multiple myeloma (MM) remains an incurable disease. Although survival has improved, there are nevertheless diminishing durations of response to each subsequent line of therapy. This highlights the need for further therapeutic innovation. BCMA-targeting CAR-T cells show impressive response rates; however, their median duration of response is disappointing. The investigators propose that CS1(SLAMF7)-targeting CAR-T cells will fill a gap in the MM armamentarium.
CS1 is an attractive target in MM because it is expressed in most patients. Elotuzumab (Empliciti®), an approved anti-CS1 antibody, has proven the clinical efficacy of this target. CAR-T cells are an ideal modality to target CS1, given that two approved treatments, ide-cel (idecabtagene vicleucel, AbecmaTM) and cilta-cel (ciltacabtagene autoleucel, Carvykti™), have proven the potential for cellular immunotherapy in MM.
The investigators are testing the safety and preliminary anti-myeloma efficacy of WS-CART-CS1, a CAR-T cell therapy targeting CS1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation: WS-CART-CS1 | Experimental | Biological: WS-CART-CS1, Drug: Lymphodepleting chemotherapy* Undergo apheresis procedure for WS-CART-CS1 manufacturing. * Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician. * Lymphodepleting chemotherapy on days -5, -4, and -3. * Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused. * Part A is the dose escalation portion of the study. |
| Part B Dose Expansion: WS-CART-CS1 | Experimental | Biological: WS-CART-CS1, Drug: Lymphodepleting chemotherapy* Undergo apheresis procedure for WS-CART-CS1 manufacturing. * Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician. * Lymphodepleting chemotherapy on days -5, -4, and -3. * Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused. * Part B is the dose expansion portion of the study. The dose of WS-CART-CS1 will be determined in Part A of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Relapsed or refractory multiple myeloma after 3 or more prior lines of therapy, including proteasome inhibitor (e.g. bortezomib or carfilzomib), anti-CD38 therapy (e.g. daratumumab), and anti-BCMA therapies (e.g. BCMA bispecific antibodies or BCMA CAR-T)
- Measurable disease, defined as meeting at least one of the following criteria:
- At least 18 years of age.
- ECOG performance status ≤ 1
- Adequate renal, hepatic, respiratory, and cardiovascular function, as defined below:
Key exclusion criteria (9 listed)
- Any prior systemic therapy for multiple myeloma within 14 days before planned day of leukapheresis.
- A history of other malignancy with the exception of treated non-melanomatous skin cancers and malignancies for which all treatment was completed at least 2 years before registration and the subject has no evidence of disease.
- Currently receiving any other investigational agents.
- Receipt of any cellular therapy within 8 weeks prior to the planned start of conditioning.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CS1 CAR-T or other agents used in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WS-CART-CS1-Subject will be hospitalized for 7 days | Biological | Part A Dose Escalation: WS-CART-CS1, Part B Dose Expansion: WS-CART-CS1 |
| Lymphodepleting chemotherapy* Cyclophosphamide 500 mg/m^2 IV on Days -5, -4, and -3 * Fludarabine 30 mg/m^2 IV on Days -5, -4, and -3 | Drug | Part A Dose Escalation: WS-CART-CS1, Part B Dose Expansion: WS-CART-CS1 |
Primary outcome
Part A: Frequency and severity of treatment-emergent adverse events
Time frame: From leukapheresis through 24 months after WS-CART-CS1 infusion (approximately 24 months and 1 week)
* Graded by CTCAE v 5.0. * Adverse events will be tracked at the time of leukapheresis through 28 days post leukapheresis, to capture any AEs related to leukapheresis only. * Adverse events will then be collected beginning with lymphodepletion chemotherapy and continue through Day 100 post WS-CART-CS1 infusion or until initiation of another anticancer therapy, whichever occurs first. * After Day 100, only targeted AEs will be reported through 24 months after WS-CART-CS1 infusion or until disease progression or relapse, whichever occurs first. Targeted AEs include and are limited to secondary malignancies, CRS, ICANS, prolonged cytopenia (defined as Grade 3 neutropenia or thrombocytopenia lasting more than 28 days after WS-CART-CS1 infusion), and SAEs or SUSARs that are not attributable to progressive disease or extraneous causes.
Part A: Frequency of dose-limiting toxicities (DLTs)
Time frame: From WS-CART-CS1 infusion through 28 days
DLTs are defined in the protocol.
Part B: Frequency and severity of treatment-emergent adverse events
Time frame: From leukaphereis through 24 months after WS-CART-CS1 infusion (approximately 24 months and 1 week)
* Graded by CTCAE v 5.0. * Adverse events will be tracked at the time of leukapheresis through 28 days post leukapheresis, to capture any AEs related to leukapheresis only. * Adverse events will then be collected beginning with lymphodepletion chemotherapy and continue through Day 100 post WS-CART-CS1 infusion or until initiation of another anticancer therapy, whichever occurs first. * After Day 100, only targeted AEs will be reported through 24 months after WS-CART-CS1 infusion or until disease progression or relapse, whichever occurs first. Targeted AEs include and are limited to secondary malignancies, CRS, ICANS, prolonged cytopenia (defined as Grade 3 neutropenia or thrombocytopenia lasting more than 28 days after WS-CART-CS1 infusion), and SAEs or SUSARs that are not attributable to progressive disease or extraneous causes.
5 secondary outcomes
Part A MTD and Part B: Disease-specific objective response rate (ORR)
Time frame: Within 3 months of WS-CART-CS1 infusion
Part A MTD and Part B: Minimal residual disease (MRD) negativity in the marrow
Time frame: Week 12
Part A MTD and Part B: Duration of response (DoR)
Time frame: -From response 24 months after WS-CART-CS1 infusion (estimated to be 24 months)
Part A MTD and Part B: Progression-free survival (PFS)
Time frame: From WS-CART-CS1 infusion through completion of follow-up (estimated to be 15 years)
Part A MTD and Part B: Overall survival (OS)
Time frame: From WS-CART-CS1 infusion through completion of follow-up (estimated to be 15 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armin Ghobadi, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WS-CART-CS1 and Lymphodepleting chemotherapy in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armin Ghobadi, M.D. (314-747-2743, arminghobadi@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Frequency and severity of treatment-emergent adverse events (time frame: From leukapheresis through 24 months after WS-CART-CS1 infusion (approximately 24 months and 1 week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.