(TNX-1500) in Kidney Transplant Recipients

NCT07204080 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025P-------
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective is to investigate the safety and efficacy 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

Keywords

Kidney Transplant; New Immunosuppression

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  12 Months

Secondary Outcomes (9)

• Incidence of Biopsy Proven Acute Rejection

  12 months

• Incidence of treatment for acute rejection

  12 Months

• Incidence of de novo DSA development

  Months 1, 3, 6, 9, 12

• Incidence of serious opportunistic infections and malignancies

  12 months

• GFR measurement

  12 months

Study Arms (1)

Kidney Transplant Recipient

EXPERIMENTAL

Drug: TNX-1500; Procedure: Kidney Transplant

Interventions

TNX-1500 DRUG

This is an open-label, single-center, single-arm study to assess the safety and efficacy of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients.

Kidney Transplant Recipient

Kidney Transplant PROCEDURE

Kidney Transplant

Kidney Transplant Recipient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or second transplant)
• Ability to understand the study requirements and provide written informed consent.
• Epstein-Barr virus (EBV) seropositive

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Ayman Al Jurdi, MD: lead
• Tonix Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ayman Al Jurdi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman Al Jurdi, Principal Investigator, MD

CONTACT

617-726-2000; aaljurdi@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 2, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)