Actively Recruiting
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Led by Polina Stepensky · Updated on 2025-05-14
180
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to evaluate the efficacy and safety of HBI0101 CART.
CONDITIONS
Official Title
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of signing informed consent
- Signed informed consent form voluntarily
- Diagnosis of relapsed or refractory multiple myeloma and/or light-chain amyloidosis with measurable disease
- Multiple myeloma patients must have had at least two prior therapies including proteasome inhibitor, immunomodulatory therapy, or anti-CD38 antibody, or be functionally high-risk
- Amyloidosis patients must have had at least one prior therapy including proteasome inhibitor or anti-CD38 antibody, or have insufficient response after such treatments
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Women of child-bearing potential must have a negative pregnancy test before treatment and agree to use effective birth control during the study
- Recovery to Grade 2 or baseline of any non-hematologic toxicities from prior treatments, excluding alopecia and Grade 3 neuropathy
- Ability and willingness to follow study visit schedule and protocol
- Relapsed multiple myeloma patients with prior allogenic stem cell transplant must have no graft versus host disease and be off immunosuppressive therapy for at least one month before enrollment
You will not qualify if you...
- Contraindications to study treatment or procedures
- Known bulky central nervous system disease
- Liver function tests above specified limits (AST/ALT > 2.5x ULN, bilirubin > 4x ULN)
- Poor kidney function (creatinine clearance < 20 ml/min)
- Blood clotting times (INR or PTT) over 2x ULN unless on stable anticoagulant therapy
- Bone marrow function below specified thresholds (ANC < 1000/mm3, platelets < 30,000/mm3, hemoglobin < 8 g/dL)
- Echocardiogram showing left ventricular ejection fraction below 40%
- Ongoing chronic immunosuppressant treatment except low-dose steroids
- Significant other medical conditions that increase risk or interfere with the study
- Known HIV infection
- Active Hepatitis B or C infection
- Active CMV infection
- Recent serious cardiovascular events or unstable heart conditions
- Second primary cancers requiring treatment in last 2 years or not in remission
- Recent venous thromboembolic events with unstable anticoagulation or bleeding
- Pregnant or breastfeeding women
- Participation in another interventional clinical trial within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hadassah MO
Jerusalem, Israel, 9574869
Actively Recruiting
Research Team
P
Polina Stepensky, MD
CONTACT
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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