CD19/BCMA CAR-T for SLE
ConditionSLE - Systemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Ucello Biotechnology Co., Ltd.
About this trial
The purpose of this clinical trial is to learn if CD19/BCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19/BCMA CAR-T cell product.
The main questions it aims to answer are:
1. What CAR-T-related adverse events (AEs) occur within 3 months after the CAR-T cell infusion? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS?
Participants will:
1. Receive CD19/BCMA CAR-T cells infusion on Day 0. 2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 3. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after CAR-T cells infusion.
Eligibility criteria
Qualifiers
Aged 18 to 65 years (inclusive), regardless of gender.
Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
Treatment refractory: failed ≥ 2 Conventional SLE treatments for at least 3 months.
Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.
Disqualifiers
History of severe drug allergies or atopic diathesis.
Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
Cardiac function insufficient to tolerate the study treatment.
Congenital immunoglobulin deficiency.
Trial design
Treatments tested in this trial
- CD19/BCMA CAR T-cells
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Chengdu Ucello Biotechnology Co., Ltd.
Lead sponsor
The General Hospital of Western Theater Command
Collaborator
Source ClinicalTrials.gov