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New treatment option for Highly Sensitized Patients Awaiting Kidney Transplant
Official title CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants
ClinicalTrials.gov ID: NCT07350837
What this study is testing
What is AZD0120?
AZD0120 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for highly sensitized patients awaiting kidney transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
- 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
You likely can't join if
- 1\. Previous solid organ (except kidney) or bone marrow transplant. 2. Complement 3 glomerulopathy, immune-complex mediated membranoproliferative...
- 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...
- 6\. History of HIV regardless of treatment. 7. Evidence of active hepatitis B infection based on positive HBsAg or positive core antibody (anti HBc)...
- 8\. Evidence of active hepatitis C infection - Positive HCV antibody: Participants with positive HCV antibody and negative HCV RNA test during the...
- 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...
See the full eligibility criteria
Who can 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:
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.