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 groupSponsors 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