Kidney TransplantPhase 2TONIX-1500NCT07204080
(TNX-1500) in Kidney Transplant Recipients
A Phase 2 study testing TNX-1500 and Kidney Transplant in people with Kidney Transplant and Kidney Transplant Failure and Rejection, run by Ayman Al Jurdi, MD at 2 sites in United States.
Trial summary
The primary objective is to investigate the safety of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant, Kidney Transplant Failure and Rejection, Immunosuppression
- What is being tested?
- TNX-1500 and Kidney Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 30 Nov 2029
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥18 to 75 years of age.
- Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital.
- Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo)
- Ability to understand the study requirements and provide written informed consent.
- Epstein-Barr virus (EBV) seropositive
Who cannot join
- Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance.
- Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.
- Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.
- Left ventricular ejection fraction < 40% as determined by TTE or clinical evidence of heart failure.
- Any of the following ocular history or ocular findings at screening exam:
- Active inflammation in either or both eyes (does not include pigment cell in the AC after dilation); must be greater than trace cell or trace flare to exclude.
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- Findings that would impact the ability to monitor, diagnose, manage, and follow new onset ocular inflammation.
- Receipt of ocular corticosteroids (topically, intravitreally, or periocularly) or has been treated with anti-VEGF intravitreal therapy within three months of Screening Exam
- Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
- Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include:
- Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.
- Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject.
- Use of injected or implanted hormonal methods of contraception or other hormonal contraception that have comparable efficacy (<1% for example, hormone vaginal ring or placement of a long-acting reversible contraceptives, an intrauterine device, or intrauterine system.
- Total abstinence
- Use of other investigational products or enrollment in another investigational drug study within 30 days prior to screening or 5 half-lives, whichever is longer.
- Subjects with clinically significant lab abnormalities (>2.5 x the upper limit of normal (ULN) of the following liver function chemistries unless due to, as judged by the investigator, a benign underlying condition:
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
- Alkaline phosphatase (ALP)
- Bilirubin
- Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT))
- Any other clinically significant medical condition, active infection, laboratory abnormality, or psychosocial condition (e.g. history of substance use disorder) that would, in the judgement of the investigator, impact the subject's ability to participate in the trial.
- Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) >20% based upon results within 6 months prior to transplant.
- Virtual crossmatch (VXM) positive transplant with an MFI >1000 as assessed by routine methodology (Luminex)
- Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative
- Multi-organ transplant or tissue recipient.
- History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix
- Subjects with any of the following: hemoglobin <8 mg/dL, white blood cell ≤2,000/mm3, or platelet count ≤75,000/mm3.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ayman Al Jurdi, MD
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ayman Al Jurdi, 617-726-2000, aaljurdi@mgh.harvard.edu
About this study
Official title: Phase II Clinical Trial Evaluating the Safety Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients
The primary objective is to investigate the safety of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.
- Conditions
- Kidney Transplant, Kidney Transplant Failure and Rejection, Immunosuppression, Immunosuppression After Kidney Transplantation
- Being tested
- TNX-1500, Kidney Transplant
- Keywords
- Kidney Transplant, New Immunosuppression
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-1500Drug
This is an open-label, single-center, single-arm study to assess the safety of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients.
Kidney TransplantProcedure or surgery
Kidney Transplant
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipient | Experimental | Not described Receives: Drug: TNX-1500; Procedure: Kidney Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events in each subject
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
Measured: 12 Months
Number of Serious Adverse Events in each subject
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
Measured: 12 Months
Secondary outcomes (11)
Incidence of Biopsy Proven Acute Rejection
Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)
Measured: 12 months
Incidence of treatment for acute rejection
Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)
Measured: 12 Months
Incidence of de novo DSA development
Measured: Months 1, 3, 6, 9, 12
Incidence of serious opportunistic infections
based upon AE/SAE data and available quantitative and qualitative EBV and CMV surveillance data
Measured: 12 months
Incidence of malignancies
based upon AE/SAE data and available documenting incidence of malignancy of any grade
Measured: 12 months
Incidence of AEs of Special Interest
based upon AESE/SAE data and available documenting incidence of AESI which include thromboembolic events, Infections >Grade 2, Any Grade 2 or higher injection site reactions, Any Grade 2 or higher cytokine release syndrome, opthamalic adverse events.
Measured: 12 months
GFR measurement
Assessment of renal function through the estimated glomerular filtration rate at 12 months post-transplant
Measured: 12 months
Incidence of death
Measured: 12 months
Incidence of graft loss
Measured: 12 months
Degree of Proteinuria
Proteinuria by urine protein-to-creatinine ratio
Measured: 12 Months
Degree of albuminuria
Albuminuria by urine microalbumin-to-creatinine ratio
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayman Al Jurdi, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Tonix Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Ayman Al Jurdi, MD, Massachusetts General Hospital
- Investigators
- Ayman Al Jurdi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204080
- Sponsor's protocol ID
- 2025P-------
- Acronym
- TONIX-1500
- Status last verified
- Feb 2026
- First submitted
- 25 Sep 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No