Actively Recruiting
Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2025-09-22
10
Participants Needed
1
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic leukemia (r/r B-ALL) or relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). The main questions it aims to answer are: 1. The safety and feasibility of autologous CART-19/22 in children, adolescents and young adults with a CD19+/- CD22+ relapse/ refractory disease for a r/r B-ALL. 2. The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r/r T-ALL.
CONDITIONS
Official Title
Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory CD19+/– CD22+ B-ALL or T-ALL not responding to conventional chemotherapy
- Suitable for allogeneic hematopoietic stem cell transplant and willing to proceed if remission occurs
- For T-ALL, presence of a suitable haploidentical donor
- Lansky (if under 16 years) or Karnofsky (if 16 years or older) score of 50 or higher
- Life expectancy greater than 12 weeks
- Absolute neutrophil count of at least 500/µL unless reversible due to leukemia therapy
- Platelet count of at least 50,000/µL unless reversible due to leukemia therapy
- Absolute lymphocyte count of at least 100/µL
- Adequate kidney, liver, lung, and heart function
- Adequate venous access with no contraindications for lymphoapheresis
- Well-controlled seizure disorder allowed
- Ability to provide written informed consent by patient or legal representative
You will not qualify if you...
- Participation in another clinical trial within the past 4 weeks
- Active infection requiring systemic treatment or uncontrolled viral reactivation
- Severe heart problems including low heart function or significant pericardial effusion
- Presence of CNS-3 disease or uncontrolled seizures
- Active immunosuppressive therapy except low-dose prednisone within 7 days before enrollment
- Severe kidney impairment (GFR below 30 ml/min) or high bilirubin levels (unless Gilbert's syndrome)
- Any condition that may affect trial safety or effectiveness as judged by the investigator
- Pregnant or breastfeeding women
- Sexually active patients must agree to effective birth control for at least 12 months post-infusion until CAR-T cells are no longer detected
- Male partners of female participants must use condoms during intercourse for at least 12 months post-infusion until CAR-T cells are no longer detected
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
A
Antonio Pérez Martínez, MD
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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