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Cord blood cells aim to tame deadly transplant complication

NCT ID NCT07576699

Disease control Sponsor: Cellenkos, Inc. 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new treatment called CK0802 for people with severe graft-versus-host disease (GVHD) that does not respond to steroids. GVHD is a serious complication after a bone marrow or stem cell transplant, where donor immune cells attack the patient's body. CK0802 uses immune cells from donated cord blood to try to calm this attack. The study will include 12 participants and will check for safety and whether the disease improves.

What this could mean

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

Active substance
CK0802 (immune cells from donated cord blood)
What this could lead to
If it works, this could offer a new treatment option for people with severe graft-versus-host disease that does not respond to steroids.
What could go wrong
This is a very early, small trial with only 12 participants. The treatment may not work or could cause serious side effects. It is not yet proven safe or effective.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

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

12 years and older

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.

Inclusion Criteria: * 1\. Age ≥12 years old (first 3 subjects will be ≥ 18 years) * 2\. Grade 2-4 acute GVHD (aGVHD) at baseline * 3\. No other prior aGVHD treatment * 4\. Steroid Refractory * Progressed after 3 days of treatment with 2 mg/kg methylprednisolone (MPE) * No improvement after 7 days of treatment with 2 mg/kg MPE * Progressed to a new organ after treatment with 1 mg/kg MPE for skin or upper gastrointestinal (UGI) aGVHD * Progressed from nadir during or after a steroid taper * 5\. Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test. * 6\. Agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up. * 7\. Willing and able to provide written informed consent. * 8\. Signed informed consent Exclusion Criteria: * 1\. 30 days prior treatment with any other investigational agent after allogeneic HSCT. * 2\. Known HIV seropositivity. * 3\. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility. * 4\. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and/or impair the activity of CK0802. * 5\. Subjects who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

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

Steroid refractory graft versus host disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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