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

NCT06101381 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-12-09

No results posted yet for this study

Summary

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

  • Leukemia, Acute Lymphoblastic
  • Lymphoma, Non-Hodgkin

Interventions

BIOLOGICAL

CART-19

The 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.

Sponsors & Collaborators

  • Blood Center of Ribeirao Preto

    collaborator UNKNOWN

  • Hospital das Clínicas de Ribeirão Preto

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Diego V Cle, MD, PhD, MBA · Ribeirao Preto School of Medicine, University of Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101381 on ClinicalTrials.gov