Allogeneic UCB-derived CAR-T for SLE
ConditionSLE - Systemic Lupus Erythematosus
Trial statusRecruiting
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 allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.
Eligibility criteria
Qualifiers
Aged 18 to 75 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
- allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
Treatment groups
48 Participants
are divided into 1 treatment groupLocations
2Yancheng Third People's Hospital YanchengJiangsu, China
The General Hospital of Western Theater Command ChengduSichuan, China
Sponsors and collaborators
Chengdu Ucello Biotechnology Co., Ltd.
Lead sponsor
The General Hospital of Western Theater Command
Collaborator
Yancheng Third People's Hospital
Collaborator
Source ClinicalTrials.gov