Actively Recruiting
CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL
Led by Bambino Gesù Hospital and Research Institute · Updated on 2025-12-02
26
Participants Needed
1
Research Sites
858 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).
CONDITIONS
Official Title
CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of T-ALL or LL with more than 98% CD7 expression on blast cells
- In 1st or later relapse after at least one standard frontline chemotherapy with bone marrow involvement
- Relapse after allogeneic hematopoietic stem cell transplant, at least 100 days post-transplant, no active GVHD, and off immunosuppressive agents for at least 30 days
- CNS disease with more than 5 white blood cells per microliter in cerebrospinal fluid and blast evidence or biopsy-proven recurrence in eye or brain
- Extramedullary relapse with blast evidence in testis or other extramedullary sites
- Refractory disease with measurable residual disease over or persistently positive at the end of consolidation in newly diagnosed patients
- Age between 6 months and 25 years
- Adequate venous access for apheresis or eligibility for catheter placement
- Voluntary informed consent obtained; assent from patients 12 years or older when appropriate
- Clinical performance status: Karnofsky score 60% or higher for patients over 16 years, Lansky scale 60% or higher for patients under 16 years
You will not qualify if you...
- Severe, uncontrolled active infections
- HIV, active hepatitis B or C infection
- Blast contamination in peripheral blood over 5% at leukapheresis
- Recent systemic steroids (high dose) or chemotherapy within 2 weeks before leukapheresis
- Recent nelarabine, daratumomab, or clofarabine within 3 weeks before leukapheresis
- Recent anti-thymocyte globulin or alemtuzumab within 8 weeks before leukapheresis
- Immunosuppressive agents within 2 weeks before leukapheresis
- Radiation therapy less than 2 weeks before leukapheresis
- Other investigational anti-cancer agents within 30 days before leukapheresis
- Pregnant or lactating women
- Life expectancy less than 6 weeks
- Inadequate liver or kidney function as defined by lab values
- Blood oxygen saturation below 90%
- Cardiac function below specified thresholds or significant heart disease
- Uncontrolled seizures or decreased consciousness
- Active grade 2 or higher acute or extensive chronic graft-versus-host disease
- Treatment with certain steroids, chemotherapy, immunosuppressants, or radiation within specified time frames before infusion
- Contamination of products with more than 5% blasts
- Psychiatric or social conditions limiting study compliance or posing risk as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ospedale Pediatrico Bambino Gesù
Rome, Rome, 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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