New cell therapy aims to supercharge Kids' immune cells after transplant
NCT ID NCT07518654
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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2 to 12 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHU Sainte-Justine
Montreal, Quebec, H3T1C5, Canada
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The Hospital for Sick Children
Toronto, Ontario, M5G1E8, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Nine-Week group program help blood cancer patients grow through trauma?
- Vaccine aims to train immune system against blood cancers
- Aloe vera mouthwash tested against chemotherapy mouth sores
- Can a smart platform ease the toll of childhood cancer on families?
- Can blood tests predict transplant complications?