RECRUITINGPhase 1INTERVENTIONAL
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
About This Trial
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Subjects voluntary agreement to provide written willing to sign a consent form.
2. Aged 18 to 70 years, either sex.
3. your organs (liver, kidneys, etc.) are working well enough based on blood tests meet screening criteria.
4. Positive test for cluster of differentiation antigen 19 (CD19).
SLE:
- Have been diagnosed of SLE at least 6 months before screening.
- At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
- Fulfill relapsed/refractory SLE conditions.
IIM:
- Have been diagnosed of IIM before screening.
- Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
- Fulfill relapsed/refractory IIM conditions.
Who Should NOT Join This Trial:
1. Active infections such as hepatitis and tuberculosis.
2. Other autoimmune conditions (where your immune system attacks your own body)s.
3. Serious underlying diseases such as tumor, uncontrolled diabetes.
4. Female subjects who were pregnant, breastfeeding.
5. Those with a history of major organ transplantation.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Subjects voluntary agreement to provide written informed consent.
2. Aged 18 to 70 years, either sex.
3. Adequate organ function meet screening criteria.
4. Positive test for cluster of differentiation antigen 19 (CD19).
SLE:
* Have been diagnosed of SLE at least 6 months before screening.
* At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
* Fulfill relapsed/refractory SLE conditions.
IIM:
* Have been diagnosed of IIM before screening.
* Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
* Fulfill relapsed/refractory IIM conditions.
Exclusion Criteria:
1. Active infections such as hepatitis and tuberculosis.
2. Other autoimmune diseases.
3. Serious underlying diseases such as tumor, uncontrolled diabetes.
4. Female subjects who were pregnant, breastfeeding.
5. Those with a history of major organ transplantation.
Treatments Being Tested
BIOLOGICAL
LUCAR-G79D T cells
Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Locations (5)
The Third The People's Hospital of Bengbu
Bengbu, Anhui, China
Nanfang Hospital
Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China