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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age: 18\

‣ 65 years old

• Diagnosis of B-cell mediated autoimmune rheumatic diseases - SLE, SSc, IIM, RA.

• Expected survival period ≥ 3 months;

• Serum creatinine \<221.0μmol/L (2.5mg/dl);

• AST/ALT below 3 times the upper limit of normal, blood bilirubin \<34.2 μmol/L (2.0 mg/dl);

• 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;

• Physical fitness score 0\

‣ 2 points (ECOG standard);

• There are suitable veins for blood cell apheresis or whole blood collection, and there are no contraindications for blood collection;

⁃ 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;

⁃ Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative;

Locations
Other Locations
Israel
Hadassah MO
RECRUITING
Jerusalem
Contact Information
Primary
Polina Stepensky, MD
Fainak@hadassah.org.il
972-2-6778353
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2030-11-01
Participants
Target number of participants: 60
Treatments
Experimental: BCMA CART
Each subject subjects will receive a single dose of 450 x 10\^6 or 800 x 10\^6 BCMA CART cells
Sponsors
Leads: Polina Stepensky

This content was sourced from clinicaltrials.gov