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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CART-19
Biological/VaccineThe academic CART-19 consists of autologous T lymphocytes transduced with a lentiviral vector to express a second-generation chimeric antigen receptor with a single chain variable fragment (scFv) targeting the CD19 antigen conjugated with 4-1BB co-stimulatory and CD3z signaling domains.
Treatment groups
81 Participants
are divided into 1 treatment groupGroup A: CD19-directed CAR-T cellExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety: Number of participants who experience early adverse events.
To evaluate the occurrence of early adverse events related to the study treatment, from inclusion until 30 days after CAR-T cell infusion.
Time frame
From patient's inclusion until 30 days after CAR-T cell infusion2
Safety: Number of participants who experience late adverse events.
To evaluate the occurrence of early adverse events related to the study treatment, from week 5 to week 52.
Time frame
From week 5 to week 52Secondary outcomes
1
Efficacy: Overall Response Rate (ORR)
The combined number of participants achieving Complete Response (CR) or Partial Response (PR) as the best response at day 30 and day 90 after CAR-T cell infusion, determined by the investigators, following Lugano criteria in non-Hodgkin lymphomas; or the combined number of participants achieving Complete Remission (CR) or Complete Remission with Incomplete Hematologic Recovery (CRi) as the best response at day 30 and day 90 after CAR-T cell infusion, determined by the investigators, in Acute Lymphoblastic Leukemia.
Time frame
Day 30 and day 90 after CAR-T cell infusion2
Efficacy: Event Free Survival (EFS)
The time between patient's inclusion and relapse, disease progression, or death of any cause.
Time frame
From patient's inclusion until 5 years3
Efficacy: Relapse Free Survival (RFS)
The duration of response, defined as the time from the first complete or partial response to the date of first documentation of relapse, disease progression, or death of any cause.
Time frame
From patient's inclusion until 5 years4
Efficacy: Overall Survival (EFS)
The number of participants surviving since patient's inclusion until 5 years
Time frame
From patient's inclusion until 5 yearsOther outcomes
1
Exploratory: Number of patientes with CAR-T cell persistence over the time
To evaluate the persistence of infused CAR-T cells in patient's peripheral blood over the time
Time frame
From CAR-T cell infusion until 5 years2
Exploratory: Replication-competent lentivirus (RCL)
To evaluate the presence of replication-competent lentivirus in patient's peripheral blood, after CAR-T cell infusion, in a cohort of 10 patients.
Time frame
From CAR-T cell infusion until 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo
Lead sponsor
Blood Center of Ribeirao Preto
Collaborator
Hospital das Clínicas de Ribeirão Preto
Collaborator
Source ClinicalTrials.gov