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Could a drug combo free kidney transplant patients from lifelong pills?

NCT ID NCT04803058

Disease control Sponsor: ITB-Med LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This phase 2 study tests whether a drug called TCD601 (siplizumab), combined with donor bone marrow cells and mild chemotherapy, can train the immune system to accept a new kidney without needing lifelong anti-rejection drugs. The trial involves 18 adults receiving a kidney from a living donor. The main goal is to see if participants can safely stop all immunosuppression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Siplizumab (TCD601) combined with donor bone marrow cells and chemotherapy drugs (fludarabine and cyclophosphamide)
What this could lead to
If it works, this could allow kidney transplant recipients to stop taking lifelong anti-rejection medications, reducing side effects and improving quality of life.
What could go wrong
This is a small, early-phase trial with only 18 participants. The approach is complex and carries risks from the chemotherapy and potential rejection. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

7 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Able to understand the study requirements and provide written informed consent before any study assessment is performed * Male or female patients ≥ 18 to 65 years of age * Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor Key Exclusion Criteria: * Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol * A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix * Recipient with anti-HLA donor-specific antibody (DSA)

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplantation

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Samsung Medical University

    Seoul, South Korea

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