Actively Recruiting
Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL
Led by Bambino Gesù Hospital and Research Institute · Updated on 2025-12-02
24
Participants Needed
1
Research Sites
891 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).
CONDITIONS
Official Title
Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CD19-expressing B-cell Acute Lymphoblastic Leukemia relapse
- Relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT) OR relapsed/refractory disease with failure of frontline therapy and at least two rescue treatments including CD19/CD22-directed antibodies
- CD19+ cell count of at least 50 cells/mcl and/or minimal residual disease (MRD) of at least 10^-4
- Voluntary informed consent from patient or legal guardian; assent for children aged 12 years or older when appropriate
- Clinical performance status: Karnofsky score ≥60% for patients older than 16 years; Lansky score ≥60% for patients 16 years or younger
- Willingness to use birth control during the study and for 4 months after lymphodepletion if of child-bearing or child-fathering potential
- Negative pregnancy test for females of child-bearing potential
You will not qualify if you...
- Pregnant or breastfeeding women
- Severe, uncontrolled active infections
- Active HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV) infection
- Life expectancy less than 6 weeks or rapidly progressing disease that interferes with study completion
- Liver dysfunction: total bilirubin >4 times upper limit of normal (ULN) or ALT/AST >6 times ULN
- Kidney dysfunction: serum creatinine >3 times ULN for age
- Blood oxygen saturation below 90%
- Heart dysfunction: left ventricular ejection fraction under 45%
- Congestive heart failure, arrhythmia, psychiatric illness, or social situations limiting compliance or posing risk
- Active grade 2-4 acute or chronic graft-versus-host disease requiring steroids or immune suppression
- Relapse occurring within 60 days after alloHSCT
- Recent treatments before infusion: high-dose systemic steroids, systemic chemotherapy, anti-thymocyte globulin or Alemtuzumab within specified time frames
- Recent immunosuppressive agents, radiation therapy, or anti-cancer investigational drugs within specified intervals
- Exceptions allowed for intrathecal chemotherapy recovery and stable physiologic steroid replacement doses
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ospedale Pediatrico Bambino Gesù
Rome, Italy, Italy, 00165
Actively Recruiting
Research Team
F
Franco Locatelli, MD, PhD
CONTACT
F
Francesca del Bufalo, MD, PhD
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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