Actively Recruiting
A Phase I Trial of Memory T Cells Expressing an NKG2D Chimeric Antigen Receptor in Children, Adolescents and Young Adults With Advanced Sarcoma
Led by Antonio Pérez Martínez · Updated on 2024-04-12
18
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I, open label, prospective, single-center, non-randomized, dose escalation clinical trial aiming to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of systemic transduced donor-derived NKG2D-CAR memory T cell infusions (Arm A), and of dual treatment, with both systemic and locally transduced donor-derived NKG2D-CAR memory T cell infusions (Arm B).
CONDITIONS
Official Title
A Phase I Trial of Memory T Cells Expressing an NKG2D Chimeric Antigen Receptor in Children, Adolescents and Young Adults With Advanced Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or younger at recurrence or progression with any type of sarcoma not responding to standard therapy
- Positive NKG2DL expression in sarcoma samples, confirmed by biopsy or archived tissue
- Measurable or evaluable tumor
- Tumor accessible for intralesional CAR T cell administration (for Arm B)
- Life expectancy of at least 10 weeks
- Lansky score (for under 16 years) or Karnofsky score (16 years or older) of 50 or higher
- Recovery from acute toxic effects of prior cancer therapies
- Adequate bone marrow function with specified blood counts and no regular transfusion needs
- Normal liver and kidney function within defined lab limits
- Ability to provide informed consent
- Willingness to use effective birth control methods during and for 6 months after treatment if sexually active
You will not qualify if you...
- Participation in another treatment protocol
- Untreated active infection or clinically significant systemic illness, including cardiac disorder with LVFE below 45%, HIV infection, active or prior CMV, EBV, hepatitis B or C infections
- Significant pulmonary, hepatic, or other organ dysfunction
- Dependence on chronic corticosteroids (except replacement therapy)
- Any toxicity grade 4 or higher according to CTCAE v5.0
- Pregnancy or lactation
- History of epilepsy
- Any other condition that may interfere with trial safety or efficacy as judged by the principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario La paz
Madrid, Spain, 442944
Actively Recruiting
Research Team
A
Antonio Pérez Martínez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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