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

NCT05705570 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-25

No results posted yet for this study

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).

Conditions

  • Acute Lymphoblastic Leukemia, in Relapse
  • Acute Lymphoblastic Leukemia Refractory
  • B-cell Lymphoma Recurrent
  • B-cell Lymphoma Refractory
  • Chronic Lymphocytic Leukemia Recurrent
  • Chronic Lymphocytic Leukemia Refractory

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide 60mg/Kg on day -6

DRUG

Fludarabine

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

BIOLOGICAL

Chimeric 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)

Sponsors & Collaborators

  • Miltenyi Biotec, Inc.

    collaborator INDUSTRY

  • Nelson Hamerschlak

    lead OTHER

Principal Investigators

  • Nelson Hamerschlak, MD, PhH · Hospital Israelita Albert Einstein

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2028-05-01
Completion
2028-12-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

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 NCT05705570 on ClinicalTrials.gov