CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma

Recruiting now · Phase 1/Phase 2

Conditions studied: Leukemia, Acute Lymphoblastic, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID: NCT06101381
Run by: University of Sao Paulo
People needed: 81
Starts: 2024-03-21
Expected to finish: 2028-12-01
Last updated by the study team: 2024-12-09

Who can join

Age: 3 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For non-Hodgkin Lymphomas (B-NHL):
Provision of signed Informed Consent form;
Age between 18 and 70 years;
Performance status according to the Eastern Cooperative Oncology Group < 2;
Relapsed or refractory B-NHL of the following types (confirmed by biopsy):
Diffuse large B-cell lymphoma (DLBCL, NOS);
High-grade B-cell lymphoma (HGBCL);
Diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL-2 rearrangement;
Follicular lymphoma (FL) grade 3B; or
Transformed follicular lymphoma (tFL)
Refractory or relapsed to two or more lines of systemic therapy, with at least one scheme containing an anti-CD20 monoclonal antibody and anthracycline, as defined below:
Refractoriness: partial response (PR), stable disease (SD), or progressive disease (PD) as the best response to the last treatment, assessed by PET-CT, according to the Lugano criteria and confirmed by a new biopsy.
Relapsed disease: disease reappearance after obtaining a complete response to the last treatment, assessed by PET-CT, according to the Lugano criteria and confirmed by a new biopsy.
Have performed, or be ineligible for, autologous hematopoietic progenitor cell transplantation (ASCT). Ineligibility is defined by:
Lack of at least partial response after salvage chemotherapy; or
Failure to mobilize and/or collect hematopoietic progenitor cells (HPC), as defined by the investigator.
Measurable disease, defined as:
Nodal lesions >15 mm in the long axis, regardless of the length of the short axis, and/or
Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) >10 mm in long axis, regardless of the length of the short axis.
Adequate organ function:
Renal function defined as:
estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2
Hepatic function defined as:
Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ≤ 2.5 × ULN; and
Total bilirubin ≤ 1.5 × ULN, except for patients with Gilbert syndrome.

You may not qualify if…

For non-Hodgkin Lymphomas (B-NHL):
Previous or concurrent cancer distinct from B-NHL within 2 years before screening, except for the following:
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.
Syndromes and/or genetic diseases with impact on the hematopoietic system, including Down's syndrome, Fanconi anemia, telomeropathies, Li Fraumeni, Blackfan-Diamond anemia, or congenital immunodeficiencies;
History of previous CAR-T therapy;
History of previous solid organ transplantation;
Active central nervous system (CNS) involvement by disease, detected by image or cytology/immunophenotyping of cerebrospinal fluid (CSF);
Primary central nervous system lymphoma (PCNSL);
Primary mediastinal large B cell lymphoma (PMBCL);
Evidence of uncontrolled systemic infection (viral, bacterial, or fungal) which requires IV antibiotics, within 2 weeks before the screening visit;
Known HIV infection;
Known HTLV I and II infection;
History of previous tuberculosis;
Positive Chagas disease serology;
Hepatitis B or hepatitis C testing indicating active/ongoing infection, as defined as:
HBV: Patients with positive HBsAg are excluded. Patients with positive anti-HBc and negative HBsAg require hepatitis B PCR evaluation before randomization. Patients who are hepatitis B PCR-positive will be excluded.
HCV: Patients with positive hepatitis C antibody may be enrolled with a negative result for hepatitis C RNA before study inclusion. Patients who are hepatitis C RNA-positive will be excluded.
History of a symptomatic CNS disease (or which required treatment within the past year), such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease;
Significant cardiovascular disease defined as ≥ grade 3 New York Heart Association functional classification system of heart failure, history of myocardial infarction, uncontrolled or symptomatic arrhythmias, or unstable angina within the past 6 months before the screening;
Chronic lung disease, with hypoxemia (Oxygen saturation measured by pulse oximetry > 93% on room air), or uncontrolled within 4 weeks before the screening visit
History of an autoimmune disease (including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis) with end-organ damage or requiring systemic immunosuppression/systemic disease-modifying agents in the 2 years preceding the screening visit;
Participants with hypothyroidism receiving a stable dose of thyroid replacement hormone may be eligible.

Where it is running

Hospital de Clínicas da UNICAMP — Campinas, São Paulo, Brazil (enrolling)
Ribeirao Preto School of Medicine, University of Sao Paulo — Ribeirão Preto, São Paulo, Brazil (enrolling)
Hospital Sírio-Libanês — São Paulo, São Paulo, Brazil (enrolling)
Hospital das Clinicas de São Paulo — São Paulo, São Paulo, Brazil (enrolling)
A Beneficência Portuguesa de São Paulo — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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