RecruitingPhase 1NCT05705570

Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies

A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies


Sponsor

Nelson Hamerschlak

Enrollment

30 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).


Eligibility

Min Age: 2 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR T-cell therapy — where a patient's own immune cells are genetically reprogrammed to attack cancer cells expressing a protein called CD19 — in people with B-cell leukemia, lymphoma, or CLL that has relapsed or stopped responding to standard treatments. **You may be eligible if...** - You are between 2 and 70 years old - You have relapsed or refractory ALL (leukemia), B-cell lymphoma, or CLL that has been treated with at least two prior therapies - Your cancer tests positive for the CD19 protein - Your performance status meets criteria (ECOG ≤ 2 for adults; Lansky ≥ 50% for children under 16) - Your liver, kidney, and heart function are within acceptable limits **You may NOT be eligible if...** - Your cancer does not express CD19 - You have not received at least two prior lines of treatment - You have unacceptable organ dysfunction - You have active autoimmune disease or active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCyclophosphamide

Cyclophosphamide 60mg/Kg on day -6

DRUGFludarabine

Fludarabine 25mg/m\^2 IV on days -5 to -3

BIOLOGICALChimeric antigen receptor T cells to be implemented in a "3 + 3" design on day 0

Level -1 (1 x 105 cells/kg) Level 1 \[Starting dose\] (5 x 105 cells/kg) Level 2 (1 x 106 cells/kg) Level 3 (2 x 106 cells/kg)


Locations(1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05705570


Related Trials