Actively Recruiting
CD19-directed CAR-T Cell Therapy for Refractory or Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma: a Multicenter Phase I/II Trial.
Led by University of Sao Paulo · Updated on 2024-12-09
81
Participants Needed
5
Research Sites
N/A
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
Researchers are evaluating a new CD19-directed CAR-T cell therapy produced locally in Brazil for patients with refractory or relapsed acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). This phase I/II clinical trial aims to study the safety and effectiveness of this treatment in 81 patients who have not responded to or have relapsed after previous therapies. Participants will undergo lymphocyte collection through apheresis, followed by CAR-T cell production involving activation, transduction, and expansion. Before receiving the CAR-T infusion, patients will be hospitalized and receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for three days. On the infusion day, patients will receive a single intravenous dose of the academic CAR-T cells, with dosing adjusted based on body weight and disease type. Patients will remain hospitalized for at least two weeks after infusion for monitoring and will receive antiviral and anti-pneumocystis prevention. During the five-year follow-up, participants will be closely monitored for treatment safety, including early and late adverse events, and treatment effectiveness through measures such as response rates and survival. Evaluations include clinical assessments, laboratory tests, and toxicity monitoring. Participants must adhere to follow-up visits and treatments as required and will be observed for any side effects or complications throughout the study period.
CONDITIONS
Brief 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 provided
- For non-Hodgkin lymphoma (B-NHL) patients: age between 18 and 70 years
- For acute lymphoblastic leukemia (B-ALL) patients: age 3 to less than 25 years
- Performance status less than 2 according to ECOG (for patients 16 years or older) or at least 50% Lansky score (for younger than 16 years)
- Relapsed or refractory CD19 positive B-ALL or specified subtypes of relapsed/refractory B-NHL confirmed by biopsy
- Refractory or relapsed disease after specified prior treatments including chemotherapy
- Measurable disease by PET-CT for B-NHL patients
- Adequate organ function including renal, hepatic, and hematologic parameters
- Willingness to use effective birth control methods for 1 year after CAR-T infusion
- Ability to comply with inpatient and outpatient treatment, laboratory monitoring, and clinic visits during study participation
You will not qualify if you...
- Previous or concurrent cancer within 2 years before screening except certain treated localized cancers
- Genetic syndromes affecting the hematopoietic system
- History of previous CAR-T therapy or solid organ transplantation
- Active central nervous system involvement by disease or primary CNS lymphoma
- Evidence of uncontrolled systemic infection requiring IV antibiotics within 2 weeks before screening
- Known infections including HIV, HTLV I/II, active hepatitis B or C, tuberculosis, or Chagas disease
- History of symptomatic CNS diseases requiring treatment within the past year
- Significant cardiovascular or chronic lung disease
- History of autoimmune disease with organ damage or requiring systemic immunosuppression in past 2 years
- Recent deep vein thrombosis or pulmonary embolism or need for systemic anticoagulation
- Major surgery within 4 weeks before screening
- History or suspicion of hemophagocytic lymphohistiocytosis (HLH)
- Recent vaccination with live or attenuated virus within 1 month before screening
- Known hypersensitivity to study treatment components
- Pregnancy, lactation, or planning pregnancy during study or within 12 months after CAR-T infusion
- Any other medical condition interfering with safety or effectiveness evaluation
- Life expectancy less than 12 weeks by investigator assessment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks including chemotherapy and at least 2 weeks hospitalization post-infusion
Participants undergo lymphocyte collection followed by lymphodepleting chemotherapy and receive a single intravenous infusion of CD19-directed CAR-T cells while hospitalized.
Multiple visits during hospitalization including infusion day and monitoring
Duration - Up to 5 years
Participants are monitored for treatment efficacy and acute and late toxicities for up to five years after CAR-T cell infusion.
Regular follow-up visits over 5 years
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
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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