Highly Sensitized Patients Awaiting Kidney TransplantEarly Phase 1NCT07350837
CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants
A Early Phase 1 study testing AZD0120 in people with Highly Sensitized Patients Awaiting Kidney Transplant, run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Highly Sensitized Patients Awaiting Kidney Transplant
- What is being tested?
- AZD0120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2026to 31 Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 2. 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:
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- 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.
- 4. The participant is currently eligible for transplantation according to local standards if a graft becomes available upon completion of treatment with the study intervention.
- 5. 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.
- 10. 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.
- 12. 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.
- 13. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- 14. Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 15. Nonsterilized male participants who are sexually active with female partner of childbearing potential (See Appendix D for details):
- (a)Must agree to use one highly effective method of birth control for at least 3 years post AZD0120 infusion.
- (b)For participants who receive LDC but not AZD0120, the contraception time lasts from enrollment until 6 months after the last dose of LDC.
- (c)Must refrain from fathering a child or donating sperm within 3 years post AZD0120 infusion.
- (d)Female partner of a male participant must use one highly effective method of birth control for at least 3 years post AZD0120 infusion.
- 16. Female participants (See Appendix D for details):
- FOCBP who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control for at least 3 years post AZD0120 infusion. For FOCBP participants who receive LDC but not AZD0120, the contraception time lasts from enrollment until 12 months after the last dose of LDC. Cessation of contraception after this point should be discussed with a responsible physician.
- All FOCBP must have a negative serum pregnancy test result 3 days prior to enrollment at Screening.
- Must refrain from donating ova within 3 years post AZD0120 infusion.
Who cannot join
- 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.
- 3. Severe peripheral arterial disease is defined by the presence of resting pain and/or non healing skin ulcers.
- 4. 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.
- 6. 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.
- 8. 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.
- 9. 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).
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- 11. 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).
- 12. 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).
- 14. Active and severe disease requiring prolonged immunosuppressive therapy, except for low dose glucocorticoids (prednisone or prednisone equivalent < 10 mg/day).
- 15. 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.
- 16. CNI use within 14 days prior to Screening. 17. Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment.
- 18. 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.
- 19. 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.
- 20. Known life-threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including DMSO.
- 21. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 years after receiving study intervention.
- 22. Plans to father a child while enrolled in this study or within 3 years after receiving study intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical Collage of Huazhong University of Science & Technology
Wuhan, Hubei
Gang Chen, Ph.D, 027-83662892, gchen@tjh.tjmu.edu.cn
About this study
Official title: An Early-Phase Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting CD19 and B Cell Maturation Antigen (BCMA), for Desensitization in Highly Sensitized Participants With End Stage Kidney Disease Awaiting Kidney Transplant
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.
Read the detailed description
This is a single-arm, open-label, early-phase clinical study of AZD0120, a dual-directed CD19/BCMA CAR-T therapy in highly sensitized adult participants with ESKD awaiting kidney transplant. This study aims to evaluate the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with end-stage kidney disease (ESKD) awaiting kidney transplantation-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)-with the participants divided into Cohort 1 (with living donors) and Cohort 2 (without living donors).
- Being tested
- AZD0120
- Keywords
- Investigator-Initiated Trial, End-stage kidney disease, Dual directed CD19/BCMA CAR-T desensitization therapy, Kidney Transplantation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0120Drug
Treatment duration: A single dose of AZD0120 via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AZD0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
CK CAR transgene levels by ddPCR
Measured: Through study completion, an average of 3 years
Maximum plasma concentration (Cmax)
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Measured: Through study completion, an average of 3 years
Time to maximum plasma concentration (Tmax)
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Measured: Through study completion, an average of 3 years
Last detectable time point（AUC0-28d）
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Measured: Through study completion, an average of 3 years
Last detectable time point（Tlast）
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Measured: Through study completion, an average of 3 years
Last quantifiable concentratione (Clast)
Cytokinetics (CK) profile of AZD0120 CAR-T celltherapy
Measured: Through study completion, an average of 3 years
Circulating soluble BCMA protein levels
Blood will be collected for the measurement of the pharmacodynamics parameters
Measured: Through study completion, an average of 3 years
Depletion of BCMA-expressing B cells
Blood will be collected for the measurement of the pharmacodynamics parameters
Measured: Through study completion, an average of 3 years
Depletion of CD19-expressing B cells
Blood will be collected for the measurement of the pharmacodynamics parameters
Measured: Through study completion, an average of 3 years
Lymphocyte subsets
To evaluate immune cell and signaling responses in peripheral blood after AZD0120 infusion
Measured: Through study completion, an average of 3 years
Time to recovery of lymphocytes and B cells to baseline
To evaluate immune cell and signaling responses in peripheral blood after AZD0120 infusion
Measured: Through study completion, an average of 3 years
Levels of cytokine in peripheral blood IL1, IL2, IL4, IL6, IL8, IL10, IL12, IL13, IFN-γ, and TNF-α
To evaluate immune cell and signaling responses in peripheral blood after AZD0120 infusion
Measured: Through study completion, an average of 3 years
Change from baseline in serum immunoglobulin concentration (including IgG, IgM, IgA, and IgE and IgG subclasses 1-4)
To evaluate immune cell and signaling responses in peripheral blood after AZD0120 infusion
Measured: Through study completion, an average of 3 years
Time to nadir and recovery of IgG
To evaluate immune cell and signaling responses in peripheral blood after AZD0120 infusion
Measured: Through study completion, an average of 3 years
Change from baseline in vaccination titers for MMR(measles, mumps, and rubella (vaccine))
To measure pharmacodynamics parameters
Measured: Through study completion, an average of 3 years
Change from baseline in vaccination titers for VZV(varicellazoster virus)
To measure pharmacodynamics parameters
Measured: Through study completion, an average of 3 years
Change from baseline in vaccination titers for Tetanus
To measure pharmacodynamics parameters
Measured: Through study completion, an average of 3 years
Change from baseline in vaccination titers for HBV
To measure pharmacodynamics parameters
Measured: Through study completion, an average of 3 years
Flow cytometry for CD19 (pan B cell marker), CD20 (pan B cell marker), CD138 (plasma cells), CD23 (follicular dendritic cells), CD3 (T cells), BCMA (plasma cells), and CD68 (macrophages)
To evaluate cell composition in the lymphatic tissues after AZD01210 infusion in participants who receive kidney transplant.
Measured: Through study completion, an average of 3 years
The incidence of anti CAR AZD0120 antibody response through the duration of the study
To evaluate immunogenicity of AZD0120
Measured: Through study completion, an average of 3 years
The incidence of anti CAR AZD0120 antibody titer through the duration of the study
To evaluate immunogenicity of AZD0120
Measured: Through study completion, an average of 3 years
The incidence of anti CAR AZD0120 antibody category of response through the duration of the study
To evaluate immunogenicity of AZD0120
Measured: Through study completion, an average of 3 years
Proportion of participants who achieve a negative virtual crossmatch based on anti-HLA antibodies Luminex assay
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Proportion of participants who achieve a negative flow cytometry crossmatch
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Proportion of participants who achieve a negative CDC crossmatch
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Percentage and absolute decrease in MFI of Class I and II anti HLA antibodies from baseline to transplantation or the end of follow-up
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Decline in MFI of Class I and II anti HLA antibodies to MFI < 2000, < 3000, < 5000.
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Number and proportion of anti HLA antibodies unacceptable for kidney transplantation that were removed.
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Number and proportion of DSAs removed
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Proportion of participants achieving ≥ doubling of donor availability based on national PRA.
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Change in national PRA from baseline over time until kidney transplantation or the end of follow-up, with and without serial dilutions.
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Time to anti-HLA antibody nadir.
To evaluate the clinical efficacy of AZD0120 in reducing DSA and improving HLA compatibility
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start28 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Highly Sensitized Patients Awaiting Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Chen, Tongji Hospital
- Investigators
- Gang Chen, Principal investigator, Tongji Hospital, Tongji Medical Collage of Huazhong University of Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350837
- Sponsor's protocol ID
- D831FFS0001
- Status last verified
- Apr 2026
- First submitted
- 29 Dec 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early-Phase Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting CD19 and B Cell Maturation Antigen (BCMA), for Desensitization in Highly Sensitized Participants With End Stage Kidney Disease Awaiting Kidney Transplant
- ClinicalTrials.gov ID
- NCT07350837
- Acronym / sponsor ID
- D831FFS0001
- Keywords
- Investigator-Initiated Trial, End-stage kidney disease, Dual directed CD19/BCMA CAR-T desensitization therapy, Kidney Transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-arm, open-label, early-phase clinical study of AZD0120, a dual-directed CD19/BCMA CAR-T therapy in highly sensitized adult participants with ESKD awaiting kidney transplant. This study aims to evaluate the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with end-stage kidney disease (ESKD) awaiting kidney transplantation-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)-with the participants divided into Cohort 1 (with living donors) and Cohort 2 (without living donors).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| AZD0120 CAR-T Cell Injection | Experimental | Drug: AZD0120This 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
- PRA greater than or equal to 80% which is consistent with highly sensitized based on national criteria
Key exclusion criteria (16 listed)
- 3. Severe peripheral arterial disease is defined by the presence of resting pain and/or non healing skin ulcers.
- 4. 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.
- 6. 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.
- 8. 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.
- 9. 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0120Treatment duration: A single dose of AZD0120 via IV infusion | Drug | AZD0120 CAR-T Cell Injection |
Primary outcome
The incidence of treatment-related adverse events AE/SAE
Time frame: Through study completion, an average of 3 years
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.
Occurrence of DLTs.
Time frame: Through study completion, an average of 3 years
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.
32 secondary outcomes
Assessment of CAR transgene levels of AZD0120 in peripheral blood over time by ddPCR.
Time frame: Through study completion, an average of 3 years
Maximum plasma concentration (Cmax)
Time frame: Through study completion, an average of 3 years
Time to maximum plasma concentration (Tmax)
Time frame: Through study completion, an average of 3 years
Last detectable time point（AUC0-28d）
Time frame: Through study completion, an average of 3 years
Last detectable time point（Tlast）
Time frame: Through study completion, an average of 3 years
Last quantifiable concentratione (Clast)
Time frame: Through study completion, an average of 3 years
Circulating soluble BCMA protein levels
Time frame: Through study completion, an average of 3 years
Depletion of BCMA-expressing B cells
Time frame: Through study completion, an average of 3 years
Depletion of CD19-expressing B cells
Time frame: Through study completion, an average of 3 years
Lymphocyte subsets
Time frame: Through study completion, an average of 3 years
Time to recovery of lymphocytes and B cells to baseline
Time frame: Through study completion, an average of 3 years
Levels of cytokine in peripheral blood IL1, IL2, IL4, IL6, IL8, IL10, IL12, IL13, IFN-γ, and TNF-α
Time frame: Through study completion, an average of 3 years
Change from baseline in serum immunoglobulin concentration (including IgG, IgM, IgA, and IgE and IgG subclasses 1-4)
Time frame: Through study completion, an average of 3 years
Time to nadir and recovery of IgG
Time frame: Through study completion, an average of 3 years
Change from baseline in vaccination titers for MMR(measles, mumps, and rubella (vaccine))
Time frame: Through study completion, an average of 3 years
Change from baseline in vaccination titers for VZV(varicellazoster virus)
Time frame: Through study completion, an average of 3 years
Change from baseline in vaccination titers for Tetanus
Time frame: Through study completion, an average of 3 years
Change from baseline in vaccination titers for HBV
Time frame: Through study completion, an average of 3 years
Flow cytometry for CD19 (pan B cell marker), CD20 (pan B cell marker), CD138 (plasma cells), CD23 (follicular dendritic cells), CD3 (T cells), BCMA (plasma cells), and CD68 (macrophages)
Time frame: Through study completion, an average of 3 years
The incidence of anti CAR AZD0120 antibody response through the duration of the study
Time frame: Through study completion, an average of 3 years
The incidence of anti CAR AZD0120 antibody titer through the duration of the study
Time frame: Through study completion, an average of 3 years
The incidence of anti CAR AZD0120 antibody category of response through the duration of the study
Time frame: Through study completion, an average of 3 years
Proportion of participants who achieve a negative virtual crossmatch based on anti-HLA antibodies Luminex assay
Time frame: Through study completion, an average of 3 years
Proportion of participants who achieve a negative flow cytometry crossmatch
Time frame: Through study completion, an average of 3 years
Proportion of participants who achieve a negative CDC crossmatch
Time frame: Through study completion, an average of 3 years
Percentage and absolute decrease in MFI of Class I and II anti HLA antibodies from baseline to transplantation or the end of follow-up
Time frame: Through study completion, an average of 3 years
Decline in MFI of Class I and II anti HLA antibodies to MFI < 2000, < 3000, < 5000.
Time frame: Through study completion, an average of 3 years
Number and proportion of anti HLA antibodies unacceptable for kidney transplantation that were removed.
Time frame: Through study completion, an average of 3 years
Number and proportion of DSAs removed
Time frame: Through study completion, an average of 3 years
Proportion of participants achieving ≥ doubling of donor availability based on national PRA.
Time frame: Through study completion, an average of 3 years
Change in national PRA from baseline over time until kidney transplantation or the end of follow-up, with and without serial dilutions.
Time frame: Through study completion, an average of 3 years
Time to anti-HLA antibody nadir.
Time frame: Through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Chen principal investigator
Tongji Hospital, Tongji Medical Collage of Huazhong University of Science & Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AZD0120 in people with Highly Sensitized Patients Awaiting Kidney Transplant, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Chen (027-83662892, gchen@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of treatment-related adverse events AE/SAE (time frame: Through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.