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New cell therapy aims to supercharge Kids' immune cells after transplant

NCT ID NCT07518654

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new cell therapy called ThINKK in 12 children aged 2–12 who have had a stem cell transplant for leukemia or neuroblastoma. The therapy is designed to boost the body's natural killer (NK) cells to better fight cancer. The main goals are to check if the treatment is safe and feasible, and to see how the immune system responds.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

2 to 12 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.

Inclusion Criteria: 1. Between 2 and less than 13 years old at time of informed consent form signature. 2. Diagnosis of acute leukemia or neuroblastoma. 3. Allogenic hematopoietic stem cell transplantation 30 to 90 days prior to eligibility confirmation. 4. Blood NK cell counts ≥ 100 x 10E+6 cells/L at least once before eligibility confirmation. 5. Life expectancy of ≥ 3 months per investigator's judgment at time of eligibility confirmation. 6. Patient or legally acceptable representative has provided informed consent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. Exclusion Criteria: 1. Current grade 3 or 4 acute GvHD (per MAGIC criteria). 2. Relapse of primary malignancy, or any other active malignancy. 1. For leukemia, defined as either morphological relapse or Minimal Residual Disease (MRD) ≥0.01% as measured by flow cytometry. MRD detected by polymerase chain reaction (PCR) does not constitute an exclusion criterion. 2. For neuroblastoma, defined as a progressive disease. 3. Ongoing therapy with systemic corticosteroids (equivalent to a prednisone dose \>0.5 mg/kg/day). Patients actively undergoing corticosteroid tapering during Screening may be enrolled once they have reached a prednisone-equivalent dose ≤ 0.5 mg/kg/day with Sponsor-Investigator approval, with the expectation that the taper will continue. 4. Ongoing systemic therapy with cyclosporine. 5. Administration or planned administration of any prohibited treatment listed in ad hoc section. 6. Aspartate aminotransferase and alanine aminotransferase serum levels ≥5 times the upper limit of normal. 7. Direct bilirubin serum levels ≥3 times the ULN (unless due to Gilbert syndrome). 8. Baseline estimated glomerular filtration rate \< 50 mL/min/1.73 m2, as determined using the Bedside Schwartz equation for \< 18 years of age. 9. Grade 4 diarrhea (ie, life-threatening consequences with urgent intervention indicated). 10. O2 Sat saturation \<90% on room air by pulse oximetry. 11. Uncontrolled life-threatening symptomatic infection(s). 12. Blood pressure below the 5th percentile for age, sex, and height last 24 hours. 13. Ongoing therapy with intravenous vasopressor agent. 14. Any condition that, in the opinion of the Investigator, would compromise the safety of the patient, would prevent full participation in this study, or would interfere with the evaluation of any study endpoints. 15. Pregnancy or breastfeeding or absence of highly effective methods of contraception for males and females of childbearing potential who engage in heterosexual intercourse

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Conditions

The condition(s) this trial relates to.

acute leukemia acute lymphoblastic leukemia acute myeloid leukemia childhood leukemia leukemia Neoplasm Metastasis neuroblastoma Paroxysmal nonkinesigenic dyskinesia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  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

Locations

  • CHU Sainte-Justine

    Montreal, Quebec, H3T1C5, Canada

  • The Hospital for Sick Children

    Toronto, Ontario, M5G1E8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.