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RECRUITINGPHASE1

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

NCT07085676•Polina Stepensky

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 18\~65 years old
•2. Diagnosis of B-cell mediated autoimmune rheumatic diseases - SLE, SSc, IIM, RA.
•3. Expected survival period ≥ 3 months;
•4. Serum creatinine \<221.0μmol/L (2.5mg/dl);
•5. AST/ALT below 3 times the upper limit of normal, blood bilirubin \<34.2 μmol/L (2.0 mg/dl);
•6. Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;
•7. No obvious active infection;
•8. Physical fitness score 0\~2 points (ECOG standard);
•9. There are suitable veins for blood cell apheresis or whole blood collection, and there are no contraindications for blood collection;
•10. Women of childbearing age should have a negative serum or urine pregnancy test 48 hours before CAR T cell reinfusion, and agree to take effective contraceptive measures during the trial until the last follow-up;
+1 more criteria

Exclusion Criteria

•1. CNS disease-currently active severe CNS, including cerebritis, cerebrovascular accident (CVA), and seizures.
•2. Kidney disease-hemodialysis, Serum creatinine \>221.0μmol/L (2.5mg/dl);
•3. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) detection value is greater than 3 times the upper limit of normal (ULN); or alkaline phosphatase (ALP) or total bilirubin test value greater than 1.5 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis
•4. Cardiovascular disease: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to leukapheresis/ moderate- severe pulmonary hypertension/ severe arrhythmia (ventricular tachycardia, ventricular fibrillation, high grade ventricular block) in the past 6 months; New York heart function class (NYHA) class III- Level IV or LVEF\<45%.
•5. Lung disease: patients with interstitial lung disease (ILD) with any of the following: \*Requiring O2 therapy and or FVC≤45% of predicted or DLCO≤40% of predicted at screening. \* Evidence of pulmonary hypertension as defined as estimated RVSP\> 50 mmHg.
•6. Muscle disease: evidence of any of the following: \* Severe proximal muscle atrophy of upper or lower extremity on MRI or clinical examination. \*Finding of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), or cancer-associated myositis (myositis diagnosed within 2 years of cancer).
•7. Other uncontrolled diseases: acute diseases (such as acute pneumonia or other infection, pulmonary embolism, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to SLE/SSc/IIM/RA which in the judgment of the investigator may confound study results or place subjects at undue risk.
•8. Biologics therapy: Received biologic therapy (antibody, inhibitor or agonist) targeting T, B lymphocytes, cytokines or receptors within two months before the study or Rituximab therapy within six months before the study.
•9. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.
•10. Received live vaccine treatment within 30 days prior to Visit 2;
+7 more criteria

Locations (1)

Hadassah MO

Jerusalem, Israel

Key Dates

Start Date

September 1, 2024

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2030

Last Updated

July 25, 2025

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus Erythematosus (SLE)Systemic Sclerosis (SSc)Idiopathic Inflammatory Myopathy (IIM)Rheumatoid Arthritis (RA)

Interventions

HBI0101 CART

BIOLOGICAL

Contacts

Polina Stepensky, MD

CONTACT

972-2-6778353 Fainak@hadassah.org.il

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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