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RECRUITING
NCT07085676
PHASE1

Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases

Sponsor: Polina Stepensky

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-09-01

Completion Date

2030-11-01

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hadassah MO

Jerusalem, Israel