CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTongji Hospital
About this trial
The purpose of this study is to assess the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with ESKD awaiting kidney transplant-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)- with or without living donors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Adult men or women aged 18 to 65 years with end-stage kidney disease who are waiting for kidney transplant and require desensitization to enable safe kidney transplant.
A living donor who meets criteria for kidney donation based on national and local center-specific guidelines has been identified
Highly sensitized participants with a requirement of positive flow cytometry crossmatch, resulting from at least one DSA detected using Luminex SAB during or before Screening
A positive virtual crossmatch, using Luminex SAB (MFI ≥ 2000), obtained within 30 days of Screening and during Screening
Disqualifiers
1. Previous solid organ (except kidney) or bone marrow transplant. 2. Complement 3 glomerulopathy, immune-complex mediated membranoproliferative glomerulonephritis, or focal and segmental glomerulosclerosis as the cause of ESKD in the native kidney.
Trial design
Design model
Single group
Treatments tested in this trial
AZD0120
DrugTreatment duration: A single dose of AZD0120 via IV infusion
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: AZD0120 CAR-T Cell InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of treatment-related adverse events AE/SAE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.A SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed:Results in death and life-threatening.
Time frame
Through study completion, an average of 3 years2
Occurrence of DLTs.
Dose toxicity is defined as any TEAE that meets the following criteria which cannot be attributed to the disease under study. Dose toxicity will be evaluated according to the ASTCT criteria, and the NCI CTCAE Version 5.0.
Time frame
Through study completion, an average of 3 yearsSecondary outcomes
1
Assessment of CAR transgene levels of AZD0120 in peripheral blood over time by ddPCR.
CK CAR transgene levels by ddPCR
Time frame
Through study completion, an average of 3 years2
Maximum plasma concentration (Cmax)
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Time frame
Through study completion, an average of 3 years3
Time to maximum plasma concentration (Tmax)
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Time frame
Through study completion, an average of 3 years4
Last detectable time point（AUC0-28d）
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Time frame
Through study completion, an average of 3 yearsSponsors and contacts
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Source ClinicalTrials.gov