Actively Recruiting
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
Led by Polina Stepensky · Updated on 2026-05-06
120
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.
CONDITIONS
Official Title
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years; geriatric assessment required for those 75 or older
- Diagnosed with a B-cell mediated autoimmune rheumatic disease listed in the study
- Disease severity and treatment resistance as specified for each autoimmune condition
- Liver enzymes (AST/ALT) below 5 times normal and bilirubin below 3 times normal
- Cardiopulmonary function basically normal with oxygen saturation above 93% at rest
- No active infection
- Women of child-bearing potential must have a negative pregnancy test and agree to use birth control
- Voluntary participation with signed informed consent
- Ability and willingness to follow study visit schedule and protocol requirements
You will not qualify if you...
- History of central nervous system or spinal cord tumors or progressive neurologic disorders
- Liver function abnormalities exceeding specified limits except due to myositis
- Recent cardiovascular events or severe heart conditions
- Chronic lung disease with oxygen saturation below 90% or significant lung function impairment
- Severe muscle atrophy or muscle diseases other than the study indication
- Acute uncontrolled diseases not related to the autoimmune disease
- Recent biologic therapies or plasma exchange as specified
- Participation in other clinical trials within 3 months prior to enrollment
- Certain previous or current cancers unless treated and in remission
- History of vital organ or stem cell transplantation
- Recent disease relapse for MS or NMO patients
- Known HIV, active hepatitis B or C, or active CMV infection
- Pregnant or lactating women
- Inability to understand or follow the study protocol
- Any other significant medical conditions that may pose risk or interfere with the study
AI-Screening
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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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