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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
Drugintravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: UCAR-T cells treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the incidence rate of Dose limited toxicity (DLTs)
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of UCAR-T cells.
Time frame
Up to 28 days after infusion2
the rate of adverse events
The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included.
Time frame
up to 2 months after UCAR-T injectionSecondary outcomes
1
Proportion of patients achieving DORIS remission
Time frame
up to 2 years after UCAR-T injection2
the changes of SELENA-SLEDAI score
Time frame
up to 2 years after UCAR-T injection3
Proportion of patients achieving SRI-4 remission
Time frame
up to 2 years after UCAR-T injection4
Percentage of participants achieving maintenance of drug-free DORIS remission
Time frame
up to 2 years after UCAR-T injectionOther outcomes
1
AUC of CAR-T cells
AUC is defined as the area under the curve in 2 months.
Time frame
up to 2 months after UCAR-T injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chengdu Ucello Biotechnology Co., Ltd.
Lead sponsor
The General Hospital of Western Theater Command
Collaborator
Yancheng Third People's Hospital
Collaborator
Source ClinicalTrials.gov