CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-70
SponsorUniversity of Sao Paulo
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed Informed Consent form;
Age between 18 and 70 years;
Performance status according to the Eastern Cooperative Oncology Group < 2;
Diffuse large B-cell lymphoma (DLBCL, NOS);
Disqualifiers
Curatively treated nonmelanomatous skin cancer;
Curatively treated cervical carcinoma in situ;
Localized breast cancer treated with curative intent with no evidence of active disease; or
Localized prostate cancer undergoing active surveillance or anti-androgenic therapy, without evidence of metastatic disease.
Trial design
Treatments tested in this trial
- CART-19
Treatment groups
81 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Sao Paulo
Lead sponsor
Blood Center of Ribeirao Preto
Collaborator
Hospital das Clínicas de Ribeirão Preto
Collaborator
Source ClinicalTrials.gov