Actively Recruiting
CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma
Led by University of Sao Paulo · Updated on 2024-12-09
81
Participants Needed
5
Research Sites
245 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo
Lead Sponsor
B
Blood Center of Ribeirao Preto
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this prospective, multicentric, single-arm, phase I/II clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.
CONDITIONS
Official Title
CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 70 years for non-Hodgkin lymphoma patients
- Age between 3 and 25 years for acute lymphoblastic leukemia patients
- Performance status less than 2 for adults or at least 50% Lansky score for children under 16
- Relapsed or refractory B-NHL of specified types confirmed by biopsy or CD19 positive relapsed/refractory B-ALL
- Refractory or relapsed disease after specified prior treatments
- Eligibility or ineligibility for autologous hematopoietic progenitor cell transplantation as defined
- Measurable disease by size criteria for lymphoma patients
- Adequate organ function, including renal, hepatic, and hematologic parameters
- Willingness to use effective birth control for 1 year after CAR-T infusion
- Ability to comply with treatment and monitoring requirements
You will not qualify if you...
- Previous or concurrent cancer within 2 years except certain treated cancers
- Syndromes or genetic diseases impacting the blood system
- History of previous CAR-T therapy or solid organ transplantation
- Active central nervous system disease involvement or primary CNS lymphoma
- Active uncontrolled systemic infections requiring IV antibiotics
- Known HIV, HTLV I/II infections, or history of tuberculosis
- Positive Chagas disease serology
- Active hepatitis B or C infection
- History of symptomatic CNS disease within past year
- Significant cardiovascular or chronic lung disease
- Autoimmune diseases with end-organ damage or recent immunosuppressive treatment
- Recent deep vein thrombosis or pulmonary embolism
- Major surgery within 4 weeks
- History or suspicion of hemophagocytic lymphohistiocytosis
- Recent vaccination with live or attenuated virus
- Known hypersensitivity to study treatment components
- Pregnancy, lactation, or planning pregnancy during study or within 12 months after infusion
- Life expectancy less than 12 weeks
- Any medical condition interfering with safety or effectiveness evaluation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Hospital de Clínicas da UNICAMP
Campinas, São Paulo, Brazil, 13083-888
Actively Recruiting
2
Ribeirao Preto School of Medicine, University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14048-900
Actively Recruiting
3
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
4
Hospital das Clinicas de São Paulo
São Paulo, São Paulo, Brazil, 05403-010
Actively Recruiting
5
A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Actively Recruiting
Research Team
D
Diego V Cle, MD, PhD, MBA
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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