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New treatment option for Kidney Transplant
Official title CAR-T Cell Therapy for Desensitization in Kidney Transplantation
ClinicalTrials.gov ID: NCT06056102
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for kidney transplant.
Also referred to as Cytoxan.
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
- This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant.
- 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
- Male or female patients aged 18-65 years with kidney failure requiring hemodialysis.
- Patients must meet one of the following two criteria:
- All the following:
- Protocol-specific cPRA ≥99.5%
- No suitable living donor OR has been active in a kidney paired donation program but not received a match within 12 months
You likely can't join if
- people with indwelling catheters as primary access for hemodialysis
- Previous solid organ (except kidney) or bone marrow transplant
- BMI ≥35 kg/m\^2
- people who have preserved or oliguric urine output \> 100 cc/day with history of recurrent UTI (2 in 6 months or 3 in 1 year, see study definitions)
- people described in exclusion #4 with structural disease such as polycystic kidney disease, obstructive uropathy with nephrolithiasis or those...
- Known active current or history of invasive fungal infection; any non-tuberculous mycobacterial infection that has been active or has required...
See the full eligibility criteria
Who can join
- Male or female patients aged 18-65 years with kidney failure requiring hemodialysis.
- Patients must meet one of the following two criteria:
- All the following:
- Protocol-specific cPRA ≥99.5%
- No suitable living donor OR has been active in a kidney paired donation program but not received a match within 12 months
- Have blood group Type O or B, and predictive of a positive virtual crossmatch to an available deceased donor.
- United Network for Organ Sharing (UNOS) listed for kidney transplant for at least 1 year
- Protocol-specific cPRA ≥99.9% Protocol-specific cPRA must be rounded from three significant figures measured ≤90 days from the time of enrollment (i.e., cPRA of 0.994500 or 0.998500 would be eligible) using the...
- Based on center-specific listing policies, a cPRA in UNet Waitlist that is ≥99.5% (the candidate must be eligible for additional priority of kidneys equivalent to individuals with a 100% cPRA)
- Able to understand and give written informed consent to participate in all aspects of the study.
- Willing to stay within 2 hours of the home study site for at least 28 days after the last T cell infusion
- people of reproductive potential must agree to use contraception for at least one year after CAR T Cell infusion
- In the absence of contraindication, vaccinations must be up to date per the DAIT Guidance for Patients in Transplant Trials and include TdAP
- Positive for EBV capsid IgG
- Negative testing for latent TB infection within 3 months prior to enrollment. Testing should be conducted using either a PPD or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB). Patients with a positive...
- Hemoglobin ≥9g/dL
- ANC ≥ 1,800/μL, \> 1,200/ μL for patients with Duffy-null associated neutrophil count (DANC)
- Absolute Lymphocyte Counts ≥500/μL or CD3 T cell Count ≥150/μL
- Platelet count ≥120,000/μL
What rules you out
- people with indwelling catheters as primary access for hemodialysis
- Previous solid organ (except kidney) or bone marrow transplant
- BMI ≥35 kg/m\^2
- people who have preserved or oliguric urine output \> 100 cc/day with history of recurrent UTI (2 in 6 months or 3 in 1 year, see study definitions)
- people described in exclusion #4 with structural disease such as polycystic kidney disease, obstructive uropathy with nephrolithiasis or those otherwise at higher risk of urinary tract infections. Anuric people with...
- Known active current or history of invasive fungal infection; any non-tuberculous mycobacterial infection that has been active or has required therapy within the last year. Any infection requiring hospitalization and IV...
- History of HIV, chronic HBV, or chronic HCV, regardless of treatment
- Negative CMV serology
- Detectible viral load HBV, HCV, CMV, EBV, or BK by PCR
- Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment
- Receiving ongoing immunosuppression including corticosteroids \>5mg/day, intravenous immunoglobulin, cyclophosphamide, tacrolimus, mycophenolic acid, or azathioprine from 30 days prior to study entry
- Active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the investigator) autoimmune disease...
- Any chronic illness requiring uninterrupted anti-coagulation or anti-platelet therapy
- History of cirrhosis or severe liver disease, including abnormal liver profile (aspartate aminotransferase [AST], alanine aminotransferases [ALT] or total bilirubin \> 3 times upper limit of normal at screening (except...
- History of sickle cell disease, or systemic amyloidosis
- Cardiac clearance for transplant \> 6 months old and/or any of the following: NYHA Class III or IV heart failure, unstable angina, left ventricular ejection fraction \< 40%, a history of recent (within 6 months)...
- Moderate-severe pulmonary function abnormality, defined as resting oxygen saturation \<92% on room air or FEV1, TLC, or DLCO (after correction for hemoglobin) \<50% of predicted values
- Patients who have received any live vaccine within 30 days of planned leukapheresis
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening
- Pregnant, currently breastfeeding, or planning to become pregnant during the primary or post-transplant follow up of the study.
- Past or current social or medical problems; or findings from physical examination or laboratory testing that are not listed above, which in the opinion of investigator, may pose additional risks from participation in...
- If the subject is positive for influenza, Tamiflu® or equivalent should be administered per package insert. The subject must complete treatment and symptoms must be improving and either resolved or nearly resolved in...
- If the subject tests positive for SARS-CoV-2, the subject will be managed per institutional practice. Subject will be eligible to initiate lymphodepleting chemotherapy and CAR T cell infusion once cleared from...
- If testing is positive for another respiratory virus (e.g., as part of a multiplex respiratory pathogen panel in the course of testing for influenza or SARS-CoV-2), the lymphodepleting chemotherapy and CAR T cell...
- people must not have developed deterioration in performance status or overall clinical condition or new laboratory abnormalities that would, in the opinion of the treating investigator, render it unsafe to proceed with...
- Requirement for supplemental oxygen to maintain peripheral oxygen saturation ≥95%.
- Presence of clinically significant radiographic abnormalities on chest x-ray. Chest x-ray is not required to evaluate for radiographic abnormalities in the absence of suggestive symptoms or exam findings.
- New cardiac arrhythmia not controlled with medical management. EKG is not required to evaluate for arrhythmia in the absence of suggestive symptoms or exam findings.
- Hypotension requiring vasopressor support.
- Active infection: Diagnostic test results indicating new bacterial, fungal, or viral infection within prior 48 hours.
- people must have adhered to restrictions on pre-infusion therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
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 Boston, Massachusetts, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States. 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.