Actively Recruiting
CS1-CAR T Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory CS1 Positive Multiple Myeloma
Led by City of Hope Medical Center · Updated on 2026-04-15
30
Participants Needed
1
Research Sites
409 weeks
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
This phase I trial studies the side effects and best dose of CS1-chimeric antigen receptor (CAR) T therapy after chemotherapy in treating patients who have CS1 positive multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Immune cells can be engineered to kill multiple myeloma cells by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells using a lentiviral vector such as CS1, that allows them to recognize multiple myeloma cells. These engineered immune cells, CS1-CAR T cells, may kill multiple myeloma cells.
CONDITIONS
Official 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...
- Signed informed consent from participant or legally authorized representative
- Karnofsky Performance Status of 70% or higher
- Life expectancy of at least 16 weeks
- Confirmed diagnosis of active multiple myeloma by International Myeloma Working Group criteria
- Confirmed CS1 positive multiple myeloma by pathology evaluation
- Measurable disease by at least one of the following: serum M-protein 0.5 g/dL, urine M-protein 200 mg/24 hours, involved serum free light chain level 10 mg/dL with abnormal kappa/lambda ratio, biopsy-proven plasmacytomas 1 lesion 2 cm, or bone marrow plasma cells 30%
- Relapsed or refractory disease after at least three prior treatment regimens including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody
- Refractory to last line of therapy prior to enrollment or documented reason for not receiving required prior treatments
- At least 90 days have passed since any autologous stem cell transplant
- Total serum bilirubin 2.0 mg/dL (up to 3.0 mg/dL if Gilbert syndrome present)
- AST and ALT less than 2.5 times upper limit of normal
- Serum creatinine 2.5 times upper limit of normal or estimated creatinine clearance 40 mL/min and not on hemodialysis
- Absolute neutrophil count 1000/uL without transfusions or growth factors at screening
- Hemoglobin 8 g/dL without transfusions or growth factors at screening
- Platelet count 50,000/uL (or 30,000/uL if bone marrow plasma cells 50%) without transfusions or growth factors at screening
- Left ventricular ejection fraction 45% within 8 weeks before enrollment
- Oxygen saturation 92%
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during study and 3 months after last treatment
You will not qualify if you...
- Prior allogeneic stem cell transplantation
- Autologous stem cell transplant within 90 days before enrollment
- Use of growth factors within 14 days before enrollment
- Platelet transfusions within 7 days before enrollment
- Epstein-Barr virus positivity by PCR at enrollment
- Receiving other investigational agents or concurrent chemotherapy, biological or radiation therapy
- Known progressing or active additional malignancy within last 2 years, except treated skin cancers or in situ cervical cancer
- Unresolved toxicities from prior therapies above grade 2, except peripheral neuropathy from bortezomib
- Known active hepatitis B or C infection or HIV positive within 4 weeks prior to enrollment
- Signs or symptoms of active infection or positive blood cultures
- Active autoimmune diseases requiring prolonged immunosuppressive therapy or severe history of autoimmune disease
- Severe heart failure (NYHA Class III or IV), unstable angina, or recent myocardial infarction within 6 months
- Clinically relevant central nervous system disorders including uncontrolled seizures, stroke, severe brain injuries, dementia, cerebellar disease, or psychosis
- Known active central nervous system involvement by malignancy
- Plasma cell leukemia or symptomatic amyloidosis
- Contraindications to leukapheresis, cyclophosphamide, fludarabine, cetuximab or tocilizumab
- Dependence on corticosteroids at doses 10 mg/day prednisone or equivalent
- Inadequate venous access for leukapheresis without willingness or ability to place supportive line
- Pregnant or breastfeeding females
- Any condition judged by investigator to contraindicate study participation due to safety or compliance concerns
AI-Screening
AI-Powered Screening
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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
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