Actively Recruiting
Phase I Study of Memory-Enriched T Cells with CS1-Targeting CAR Following Chemotherapy in Adults with CS1+ Multiple Myeloma
Led by City of Hope Medical Center · Updated on 2026-04-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating CS1-chimeric antigen receptor (CAR) T therapy in adults with CS1 positive multiple myeloma that has returned or does not respond to previous treatments. This phase I trial aims to study the side effects and determine the best dose of this immune cell therapy after chemotherapy. The study focuses on how engineered immune cells, called CS1-CAR T cells, may recognize and kill multiple myeloma cells. Participants first undergo leukapheresis, a procedure to collect immune cells, lasting 2 to 4 hours. About 3 to 4 weeks later, they receive chemotherapy with cyclophosphamide or a combination of fludarabine and cyclophosphamide given intravenously over several days. On day 0, participants receive the CS1-CAR T cell therapy infusion, which takes 10 to 15 minutes. This study uses a dose-escalation design to find the safest and most effective dose. Throughout the study, participants are closely monitored with follow-up visits starting one day after treatment, then every two days for at least two weeks, weekly for one month, monthly for one year, and periodically for up to 15 years. Researchers will track side effects, responses to therapy at multiple time points, persistence of the CAR T cells in blood and bone marrow, immune activity markers, and disease progression. This long-term monitoring helps assess safety, treatment effects, and disease status over time.
CONDITIONS
Brief Title
CS1-CAR T Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory CS1 Positive Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has signed informed consent.
- Karnofsky Performance Status of 70% or higher.
- Life expectancy of at least 16 weeks.
- Confirmed diagnosis of active multiple myeloma by IMWG criteria.
- Confirmed CS1 positive multiple myeloma.
- Measurable disease by specified lab or biopsy criteria.
- Relapsed or refractory disease after at least 3 prior treatment regimens including immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody.
- At least 90 days since autologous transplant if applicable.
- Total serum bilirubin less than or equal to 2.0 mg/dL (up to 3.0 mg/dL if Gilbert syndrome).
- AST and ALT less than 2.5 times the upper limit of normal.
- Serum creatinine less than or equal to 2.5 times upper limit or creatinine clearance at least 40 mL/min, no hemodialysis.
- Absolute neutrophil count at least 1000/uL without transfusions or growth factors.
- Hemoglobin at least 8 g/dL without transfusions or growth factors.
- Platelet count at least 50,000/uL (or 30,000/uL if marrow plasma cells 50% or more) without transfusions or growth factors.
- Left ventricular ejection fraction at least 45% within 8 weeks before enrollment.
- Oxygen saturation at least 92%.
- Negative pregnancy test for women of childbearing potential.
- Agreement to use effective contraception or abstain during study and 3 months after last dose.
You will not qualify if you...
- Prior allogeneic stem cell transplant.
- Autologous transplant less than or equal to 90 days before enrollment.
- Use of growth factors within 14 days before enrollment.
- Platelet transfusions within 7 days before enrollment.
- Positive Epstein-Barr virus PCR at enrollment.
- Receiving other investigational, biological, chemotherapy, or radiation treatments.
- Active progressing malignancy within last 2 years except certain skin or cervical cancers.
- Unresolved toxicities from prior therapies except mild peripheral neuropathy.
- Active hepatitis B or C infection or HIV positive.
- Signs or symptoms of active infection.
- Active autoimmune diseases or severe autoimmune history requiring immunosuppressants.
- Severe heart failure, unstable angina, or recent heart attack within 6 months.
- Clinically relevant CNS disorders or active CNS malignancy.
- Plasma cell leukemia or symptomatic amyloidosis.
- Contraindications to leukapheresis, cyclophosphamide, fludarabine, cetuximab, or tocilizumab.
- Dependence on corticosteroids above specified doses.
- Inadequate venous access for leukapheresis.
- Pregnant or breastfeeding women.
- Any other condition deemed unsafe for participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo leukapheresis, a procedure to collect immune cells for modification.
1 visit (in-person)
Duration - 2 to 3 days
Participants receive chemotherapy drugs cyclophosphamide and/or fludarabine intravenously to prepare for CAR T cell therapy.
2 to 3 visits (in-person)
Duration - 1 day
Participants receive a single infusion of CS1-CAR T cells over 10-15 minutes.
1 visit (in-person)
Duration - Up to 15 years
Participants are monitored for safety and treatment effects with frequent visits initially, then less frequent long-term visits.
1 day visit, then visits at least every 2 days up to 14 days, weekly for 1 month, monthly for 1 year, then periodic visits
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here