Trials / Recruiting
RecruitingNCT07085676
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Polina Stepensky · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Up to 60 subjects with B-cell mediated autoimmune rheumatic diseases will be enrolled in a single-arm, open-label, single-site Phase 1 study. The study includes 2 parts. The first Part A is an establishment of the safety profile followed by a dose ranging, maximum tolerated dose (MTD) study and the second Part B is an extension phase to further evaluate safety at the selected safe dose. Eligible subjects will undergo leukapheresis procedure to provide starting material for manufacturing of HBI0101 CART investigational product. Each eligible subject will receive a single dose of HBI0101 CART cells. Prior to administration of HBI0101 CART, the study subjects will undergo lymphodepletion. Following administration of HBI0101 CART the subjects will be hospitalized for several days and then will return for routine follow-up periodical visits until 48 months after infusion.
Conditions
- Systemic Lupus Erythematosus (SLE)
- Systemic Sclerosis (SSc)
- Idiopathic Inflammatory Myopathy (IIM)
- Rheumatoid Arthritis (RA)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HBI0101 CART | HBI0101 CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The HBI0101 CART may be provided fresh or cryopreserved. |
Timeline
- Start date
- 2024-09-01
- Primary completion
- 2026-11-01
- Completion
- 2030-11-01
- First posted
- 2025-07-25
- Last updated
- 2025-07-25
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT07085676. Inclusion in this directory is not an endorsement.