CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants

NCT07350837 | Recruiting Early Phase 1

• 1 other identifier: D831FFS0001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Highly Sensitized Patients Awaiting Kidney Transplant

Keywords

Investigator-Initiated Trial; End-stage kidney disease; Dual directed CD19/BCMA CAR-T desensitization therapy; Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, an average of 3 years

• 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.

  Through study completion, an average of 3 years

Secondary Outcomes (32)

• Assessment of CAR transgene levels of AZD0120 in peripheral blood over time by ddPCR.

  Through study completion, an average of 3 years

• Maximum plasma concentration (Cmax)

  Through study completion, an average of 3 years

• Time to maximum plasma concentration (Tmax)

  Through study completion, an average of 3 years

• Last detectable time point（AUC0-28d）

  Through study completion, an average of 3 years

• Last detectable time point（Tlast）

  Through study completion, an average of 3 years

Study Arms (1)

AZD0120 CAR-T Cell Injection

EXPERIMENTAL

This study is An Early Exploratory. The main purpose is an IIT clinical trial to evaluate the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with ESKD awaiting kidney transplant.

Drug: AZD0120

Interventions

AZD0120 DRUG

Treatment duration: A single dose of AZD0120 via IV infusion

AZD0120 CAR-T Cell Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Cohort 1:
• 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
• Cohort 2:
• PRA greater than or equal to 80% which is consistent with highly sensitized based on national criteria
• At least one anti-HLA antibody that is unacceptable for kidney transplantation 3. High-resolution HLA typing for both the recipient and the donor within 2 years of Screening.
• \. The participant is currently eligible for transplantation according to local standards if a graft becomes available upon completion of treatment with the study intervention.
• \. Hemoglobin ≥ 8 g/dL. 6. ANC ≥ 800/μL. 7. Absolute lymphocyte count ≥ 2000/μL or CD3 T cell count ≥ 500/μL. 8. Platelet count ≥ 75000/μL. 9. Vaccinations must be up to date in accordance with the national and local center guidance for transplant participants.
• \. Positive for EBV capsid IgG. 11. Testing for latent TB infection must be negative within 3 months prior to Screening. Testing should be conducted using either a purified protein derivative or an IFN-γ release assay (ie, QuantiFERON-TB or T-SPOT.TB). Participants with a positive test for latent TB infection must complete appropriate therapy for LTBI.
• A participant is considered eligible if he/she has a negative test for LTBI within 3 months prior to Screening, or if he/she has completed appropriate LTBI therapy prior to transplantation. Treatment for latent TB infection should follow national guidelines.
• \. Participants must be willing to be hospitalized for at least 2 weeks from the time of AZD0120 infusion and must reside within 2 hours of the hospital for an additional 2 weeks following hospital discharge.
• \. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• \. Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if:

• \. 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.
• \. Severe peripheral arterial disease is defined by the presence of resting pain and/or non healing skin ulcers.
• \. History of recurrent UTI; 2 in 6 months or 3 in one year. 5. Active invasive bacterial, viral or fungal infection. Additionally, any infection requiring hospitalization and IV antibiotics within 4 weeks of Screening or PO antibiotics within 2 weeks.
• \. History of HIV regardless of treatment. 7. Evidence of active hepatitis B infection based on positive HBsAg or positive core antibody (anti HBc): participants with positive anti-HBc but negative HBsAg may be enrolled if the HBV DNA test result is negative during the Screening Period.
• \. Evidence of active hepatitis C infection - Positive HCV antibody: Participants with positive HCV antibody and negative HCV RNA test during the Screening Period and absence of cirrhosis may be enrolled.
• \. Detectable viral load for CMV, EBV, BKV or SARS-CoV-2, as determined by PCR. 10. CMV serology incompatible with donor (eg, a recipient with a CMV negative serology should not receive an organ from a CMV positive donor).
• \. History of cirrhosis or severe liver disease, including abnormal liver profile (AST, ALT, or total bilirubin \> 3 × ULN at Screening, except for participants whose hyperbilirubinemia is attributed to Gilbert's syndrome).
• \. History of sickle cell disease or systemic amyloidosis. 13. Any chronic illness requiring uninterrupted anticoagulation or antiplatelet therapy, except for clinical stable and asymptomatic conditions (eg, chronic atrial fibrillation).
• \. Active and severe disease requiring prolonged immunosuppressive therapy, except for low dose glucocorticoids (prednisone or prednisone equivalent \< 10 mg/day).
• \. Receiving ongoing immunosuppressive treatment, including corticosteroids (excepting \< 10 mg/d of prednisone or prednisone equivalent), IV immunoglobulin, CYC, mycophenolic acid, or azathioprine, from 90 days prior to Screening.
• \. CNI use within 14 days prior to Screening. 17. Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment.
• \. Cardiac clearance for transplant \> 6 months old and/or any of the following conditions: NYHA Class III or IV heart failure, unstable angina, LVEF \< 40%, a history of recent (within 6 months of Screening) myocardial infarction or presence of implantable cardioverter/defibrillators and/or biventricular pacing.
• \. Moderate-severe pulmonary function abnormality, defined as resting oxygen saturation \< 92% on room air or FEV1, total lung capacity, or DLCO (after correction for hemoglobin) \< 50% of predicted values within 6 months of Screening.
• \. Known life-threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including DMSO.
• \. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 years after receiving study intervention.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical Collage of Huazhong University of Science & Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gang Chen

  Tongji Hospital, Tongji Medical Collage of Huazhong University of Science & Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Chen

CONTACT

027-83662892; gchen@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Model Details: In this study, a single dose group is planned for the CAR-T cell infusion dose, and this study will enroll up to approximately 12 participants into 2 cohorts: approximately 6 highly sensitized participants with living donors (Cohort 1) and approximately 6 highly sensitized participants without living donors (Cohort 2).

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)