TNX-1500 for Kidney Transplant Rejection

(TONIX-1500 Trial)

Overseen By Ayman Al Jurdi, Principal Investigator, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ayman Al Jurdi, MD

Must not be taking: Investigational drugs

Disqualifiers: HIV, Hepatitis B, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called TNX-1500 for preventing rejection in kidney transplant patients. It focuses on individuals with chronic kidney disease or end-stage kidney disease receiving a kidney transplant from a compatible donor. Ideal participants have been diagnosed with Epstein-Barr virus (a common virus that most people contract) and are scheduled for a kidney transplant at Massachusetts General Hospital. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that TNX-1500 is likely to be safe for humans?

Research has shown that TNX-1500 is generally safe. In lab tests, it did not cause human blood cells called platelets to clump together, an important factor since clumping can lead to blood clots. Previous tests in people yielded encouraging safety results. These findings suggest that TNX-1500 is well-tolerated. However, ongoing studies aim to ensure its safety for kidney transplant patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

TNX-1500 is unique because it offers a new approach to preventing kidney transplant rejection. Unlike traditional immune-suppressing drugs that broadly dampen the immune system, TNX-1500 specifically targets a molecule called CD40L, which plays a crucial role in the immune response that leads to organ rejection. This targeted action has the potential to reduce side effects and improve the safety profile for patients. Researchers are excited because TNX-1500 could provide a more precise and effective way to protect transplanted kidneys, enhancing long-term outcomes for recipients.

What evidence suggests that TNX-1500 might be an effective treatment for kidney transplant rejection?

Research has shown that TNX-1500, a medication under study in this trial, may help prevent kidney transplant rejection. Studies have found that it can stop the body from rejecting the new kidney and improve survival rates. TNX-1500 targets a specific protein involved in the immune system, protecting the transplanted kidney from attack. Evidence suggests that TNX-1500 is as effective as similar treatments but may cause fewer side effects. This makes it a promising option for kidney transplant patients aiming to maintain a healthy new kidney. ^{2 3 6 7 8}

Who Is on the Research Team?

Ayman Al Jurdi, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for kidney transplant recipients who may be sensitive to organ rejection. Participants must meet certain health criteria, which are not specified here. People with conditions that could interfere with the study or pose a risk to their health are excluded.

Inclusion Criteria

I have received a kidney transplant that matches my blood type.

Ability to understand the study requirements and provide written informed consent

Epstein-Barr virus (EBV) seropositive

Exclusion Criteria

I have had cancer before, but it was either skin cancer that did not spread or early-stage cervical cancer.

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

Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TNX-1500, an FC-modified anti-CD154 mAb, for kidney transplant

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TNX-1500

Trial Overview The trial is testing TNX-1500, an antibody designed to prevent organ rejection, in five patients over 12 months. The goal is to see if it's safe and effective at helping the body accept a new kidney without complications.

How Is the Trial Designed?

Group I: Kidney Transplant Recipient Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Ayman Al Jurdi, MD

Lead Sponsor

Tonix Pharmaceuticals, Inc.

Industry Sponsor

Trials

31

Recruited

4,900+

Citations

1. ir.tonixpharma.com ir.tonixpharma.com/news-events/press-releases/detail/1548/tonix-pharmaceuticals-announces-positive-topline-results

Press Releases We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07204080

NCT07204080 | (TNX-1500) in Kidney Transplant Recipients Study Plan ; Incidence of treatment for acute rejection, Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria), 12 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527606/

TNX-1500, a crystallizable fragment–modified anti-CD154 ... We conclude that TNX-1500 retains efficacy similar to that of 5c8 to prevent kidney allograft rejection while avoiding previously identified pathway-associated ...

4. marketchameleon.com marketchameleon.com/articles/b/2025/11/4/tonix-tnx-1500-kidney-transplant-phase2-mgh

Tonix's TNX-1500 Targets Kidney Transplant Rejection with... The results from the American Journal of Transplantation show it can prevent organ rejection, prolong survival, and preserve graft function ...

5. medthority.com medthority.com/news/2025/3/tnx-1500-shows-promise-in-preventing-organ-transplant-rejections-of-either-human-or-pig-organs-autoimmune-diseases-also-a-target---tonix-pharmaceuticals/

TNX-1500 Shows Promise in Transplant Rejection TNX-1500 demonstrates potential in preventing organ transplant rejections and treating autoimmune diseases.

6. ir.tonixpharma.com ir.tonixpharma.com/news-events/press-releases/detail/1599/tonix-pharmaceuticals-announces-collaboration-with

Press Releases The first-in-human Phase 1 PD/PK study of TNX-1500 was completed and topline reported in first quarter 2025 to support dosing in a planned Phase ...

7. stocktitan.net stocktitan.net/news/TNXP/tonix-pharmaceuticals-presented-an-update-on-fc-modified-anti-cd40l-6bs707qztdk1.html

Tonix Pharmaceuticals Reports Phase 1 Safety Data for ... Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft ...

8. renalinterventions.net renalinterventions.net/phase-1-study-of-kidney-transplant-rejection-drug-initiated/

Phase 1 study of kidney transplant rejection drug initiated The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous (IV) TNX-1500.