A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases

Beijing GoBroad Hospital

Status and phase

Enrolling

Phase 1

Conditions

Primary Sjogren's Syndrome

Systemic Sclerosis (SSc)

Treatments

Biological: OL-CD19-GDT

Study type

Interventional

Funder types

Other

Identifiers

NCT07167537

OL-CD19-GDT-002

Details and patient eligibility

About

This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed/refractory autoimmune diseases.

Full description

This is an open-label, single-arm, clinical study to evaluate the efficacy and safety of CAR-T therapy OL-CD19-GDT in the treatment of Relapsed/ Refractory Autoimmune Diseases such as SSc and pSS.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults aged 18-65 years old
ECOG 0-2
Adequate organ function
Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP
SSc specific:

a)Fulfilling the 2013 ACR/EULAR classification criteria of SSc; b) mRSS score >10; c) at least one vital organ involvement besides the skin; d)relapsed or refractory to at least one immunosuppressant or biologic.
pSS specfic: a)Fulling the 2016 EULAR/ACR classification critieria for pSS; b) anti-Ro/anti-SSA antibody positive; c) ESSDAI score ≥5 ; d)relapsed or refractory to at least one immunosuppressant or biologic.

Exclusion criteria

Active uncontrolled infection
Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
HIV antibody positive
Syphilis antibody positive
Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)
History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)
Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)
Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment
history of organ transplant
Pregnancy or lactating women
Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug
Use of biologics within 10 weeks, stem cell transplant within 6 months prior to the start of study drug
Prior CAR-T treatment
Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1
Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.
Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure
Limited to patients diagnosed with pSS: primary biliary cholangitis