Actively Recruiting
Clinical Trial of Infusion of Activated NK Cells for the Treatment of Sarcomas
Led by Antonio Pérez Martínez · Updated on 2023-07-21
10
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an exploratory therapeutic study (according to the terminology of the "ICH Harmonised Tripartite Guideline Topic E8. General Considerations for Clinical Trials". EMEA, March 1998. CPMP/ICH/291/95), open-label, non-randomized, multicenter study. It is considered phase I/II since the safety and efficacy of the infusion of allogeneic haploidentical NK cells in combination with chemotherapy and/or radiotherapy in the treatment of pediatric, adolescent and young adult patients with refractory sarcoma will be sought.
CONDITIONS
Official Title
Clinical Trial of Infusion of Activated NK Cells for the Treatment of Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 0 and 30 years diagnosed with malignant sarcoma who have residual disease after conventional treatment or show stable/minimal disease without clinical benefit from chemotherapy
- Lansky/Karnofsky index greater than 60%
- Mild to moderate organ function impairment (hepatic, renal, respiratory) below grade 4 per NCI CTCAE v5.0
- Left ventricular ejection fraction above 39%
- Adults who provide voluntary informed consent before the first study intervention
- Minors whose legal guardian provides voluntary informed consent before the first study intervention
- Assent obtained from mature minors aged 12 to 17 years in addition to guardian consent
- Women of childbearing potential must have a negative pregnancy test at inclusion and agree to use highly effective contraception during the study and for 30 days after
- Presence of a compatible haploidentical donor (father, mother, or sibling)
You will not qualify if you...
- History of poor therapeutic compliance
- Deemed unsuitable for the procedure after psycho-social evaluation, including socio-familial situations preventing study participation
- Emotional or psychological problems related to disease requiring specialist support, such as PTSD, phobias, delirium, or psychosis
- Inability to understand information about the trial
- Severe functional organ impairment (hepatic, renal, respiratory) grade 4 or above per NCI CTCAE v5.0
- Contraindications, interactions, dose reductions noted in drug data sheets
- Received investigational drugs within 90 days before inclusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
Research Team
A
Antonio Pérez Martínez, PI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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