Can a Patient's own immune cells beat childhood cancers that Won't quit?
NCT ID NCT06566092
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a treatment made from a patient's own immune cells, called tumor-infiltrating lymphocytes (TIL). Doctors remove a piece of the tumor, grow the immune cells in a lab, and then infuse them back into the patient to attack the cancer. The study includes 40 children, teenagers, and young adults with solid tumors (like sarcoma or melanoma) that have returned or are not responding to standard treatments. The main goal is to see if the treatment is safe and tolerable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tumor-infiltrating lymphocytes (TIL)
- What this could lead to
- If it works, this could point toward a new treatment option for children and young adults with hard-to-treat solid tumors that have stopped responding to standard therapy.
- What could go wrong
- This is a very early (Phase 1) and small trial (40 people), so it is primarily testing safety, not effectiveness. The treatment may not shrink tumors, and side effects could be significant.
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
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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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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6 months to 21 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. Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and assent. 2. Histologically or cytologically confirmed recurrent or refractory solid tumor (Rhabdomyosarcoma, Ewing sarcoma, primary CNS malignancies, melanoma) after standard therapy which has failed all available curative therapy. 3. Acceptable performance status and an estimated life expectancy of \> 6 months. 4. At least one resectable lesion (solitary or aggregate lesions) for TIL generation. 5. Following tumor resection for TIL generation, the participant will have at least one remaining measurable lesion for response assessment. 6. Preplanned surgical procedure(s) will take place at least 14 days (for major operative procedures) prior to the tumor resection. 7. All prior anticancer treatment-related AEs should be recovered, exceptions are peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine dysfunction. 8. Agreement to abide by the protocol indicated contraception use, including refraining from donating sperm or eggs (ova, oocytes), as appropriate for the age and sexual activity of pediatric, adolescent, and young adult participants and as required by local regulations. 9. Signed informed consent and assent when applicable. 10. Written authorization for use and disclosure of protected health information. 11. Ability to adhere to the study visit schedule and other protocol requirements. 12. Acceptable hematologic parameters. 13. Adequate organ function. 14. Modified Ross criteria class 1 and an LVFS \> 25% or an LVEF ≥ 50%. 15. Adequate pulmonary function. 16. Participant and/or the legal guardian who provided consent is willing for the participant to receive optimal supportive care. 17. A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up and accompany the participant to the study site on each assessment day according to the SoA. Exclusion Criteria: 1. Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or carcinomatous meningitis. 2. Participant has an active or uncontrolled intercurrent illness(es) that would pose increased risks for study participation. 3. Participants are not eligible if they experience uncontrolled seizures. 4. Participants with history of intracranial hemorrhage/spinal cord hemorrhage. 5. Participant has active uveitis that requires active treatment. 6. Participant has significant psychiatric disease or substance abuse in the investigator's opinion that would prevent adequate informed consent. 7. Participant has any form of primary or acquired immunodeficiency. 8. History of clinically significant chronic obstructive pulmonary disease, asthma, interstitial lung disease, or other chronic lung disease. 9. History of hypersensitivity reaction to any components of the study intervention. 10. Any other condition that in the investigator's judgment would significantly increase the risks of participation. 11. Any complication or delayed healing from an excisional procedure that in the investigator's opinion would increase the risks of participation. 12. Another primary malignancy within the previous 3 years. 13. History of allogeneic cell or organ transplant. 14. Requiring systemic steroid therapy higher than the physiologic replacement dose. 15. Received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD. 16. Any active viral, bacterial, or fungal infection requiring ongoing systemic treatment.
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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.
Contacts and locations
Locations
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Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
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Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Roswell Park Cancer Institute
Buffalo, New York, 14203, United States
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Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A pill that blocks RAS: can it help children whose tumors came back?
- Blood test could spot Melanoma's BRAF mutation
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?