BridgeMD
Clinical trial of infusion of activated NK cells for the treatment of children, adolescents and young adults with sarcomas.
EU CTIS ID: 2024-513431-25-00
What this study is testing
To evaluate the safety of immunotherapy with haploidentical allogeneic NK cells together with IL-2 after lymphoablative chemotherapy and/or low-dose radiotherapy in pediatric, adolescent and young adult patients with refractory sarcoma.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 0-40 years diagnosed with malignant sarcoma, who at the end of conventional treatment still have detectable residual disease (based on imaging techniques) or in case of stable disease or minimal disease when there is an absence of clinical benefit from chemotherapy (poor tolerance due to adverse effects related to chemotherapy).
- Lansky/Karnofsky index > 60%.
- Mild-moderate (<4) organ functional impairment (hepatic, renal, respiratory), according to National Cancer Institute criteria (NCI CTCAE v5.0).
- Left ventricular ejection fraction >39%.
- Adult subjects who had voluntarily signed the informed consent prior to the first intervention of the study.
- Minor subjects whose representative/legal guardian voluntarily signed the informed consent prior to the first intervention of the study.
You likely can't join if
- Patients with a history of poor therapeutic compliance.
- Patients who after a psycho-social evaluation are censored as unsuitable for the procedure. Socio-familial situation that makes proper participation in the study impossible. Patients with emotional or psychological problems secondary to the disease, such as post-traumatic stress disorder, phobias, delirium, psychosis, requiring specialist support. Evaluation of the involvement of family members in the patient's health. Impossibility to understand information about the trial.
- Severe functional organ impairment (hepatic, renal, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 5.0).
- The contraindications, interactions, precautions for use and dose reductions indicated in the corresponding data sheets should be considered.
- Subjects who have been administered other investigational drugs in the 90 days prior to inclusion.
See the full eligibility criteria
- Patients aged 0-40 years diagnosed with malignant sarcoma, who at the end of conventional treatment still have detectable residual disease (based on imaging techniques) or in case of stable disease or minimal disease when there is an absence of clinical benefit from chemotherapy (poor tolerance due to adverse effects related to chemotherapy).
- Lansky/Karnofsky index > 60%.
- Mild-moderate (<4) organ functional impairment (hepatic, renal, respiratory), according to National Cancer Institute criteria (NCI CTCAE v5.0).
- Left ventricular ejection fraction >39%.
- Adult subjects who had voluntarily signed the informed consent prior to the first intervention of the study.
- Minor subjects whose representative/legal guardian voluntarily signed the informed consent prior to the first intervention of the study.
- In the case of mature minors (12 - 17 years of age), in addition to the consent signed by the legal guardian, the minor's assent will be obtained.
- Women of childbearing capacity must have a negative pregnancy test at inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or vasectomized partner) during their participation in the study and within 30 days of the last visit.
- Presence of a compatible haploidentical donor (parent or sibling).
- Patients with a history of poor therapeutic compliance.
- Patients who after a psycho-social evaluation are censored as unsuitable for the procedure. Socio-familial situation that makes proper participation in the study impossible. Patients with emotional or psychological problems secondary to the disease, such as post-traumatic stress disorder, phobias, delirium, psychosis, requiring specialist support. Evaluation of the involvement of family members in the patient's health. Impossibility to understand information about the trial.
- Severe functional organ impairment (hepatic, renal, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 5.0).
- The contraindications, interactions, precautions for use and dose reductions indicated in the corresponding data sheets should be considered.
- Subjects who have been administered other investigational drugs in the 90 days prior to inclusion.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.