Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases (NCT07085676) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
Israel120 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 18\~80 years old; for patients aged ≥ 75 years, geriatric assessment and endorsement are required;
✓. Diagnosis of B-cell mediated ARDs listed below:
✓. AST/ALT below 5 times the upper limit of normal, blood bilirubin below 3 times the upper limit of normal ;
✓. 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;
✓. No obvious active infection;
✓. There are no contraindications for blood collection;
✓. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study;
✓. Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.
Exclusion criteria
✕. CNS disease- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-autoimmune progressive neurologic condition or PML
✕. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) or alkaline phosphatase (ALP) detection value is greater than 5 times the upper limit of normal (ULN); or total bilirubin test value greater than 3 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis.
What they're measuring
1
Part A: Establishment of the initial safety profile of HBI0101 CAR T
✕. 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%.
✕. Lung disease: patients with chronic lung disease with any of the following: \* Oxygen saturation (SpO2) \< 90% on room air \* FVC≤45% of predicted or DLCO≤40% of predicted at screening. \* Evidence of pulmonary hypertension as defined as estimated RVSP\> 50 mmHg.
✕. 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).
✕. 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 indicated autoimmune diseases which in the judgment of the investigator may confound study results or place subjects at undue risk.
✕. Biologics therapy: Received rituximab within 4 months of expected CAR T treatment: No plasma exchange or immunoglobulin treatment within 4 weeks prior to screening. MS patients: No high dose corticosteroid treatment in the 30 days prior to enrollment; see also section 9.1 for the list of restrictions.
✕. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.