Suspended

CRETI-NHCD19 Chimeric Receptor-T Cells for B-Cell Non Hodgkin's Lymphoma and Leukemias

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Study Aim

This phase 1 study aims to evaluate the safety of using your own genetically modified T-lymphocytes, which target CD19, as a treatment for Non Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia, or B-Chronic Lymphocytic Leukemia.

What is being tested

CD19CAR-28-zeta T cells

+ Ipilimumab

GeneticDrug
Who is being recruted

Chronic Disease+17

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2009
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2009

Actual date on which the first participant was enrolled.

This study focuses on treating B-Cell Non Hodgkin's Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia using CD19 Chimeric Receptor Expressing T Lymphocytes. The goal is to understand the safety and long-term effects of this treatment. Participants in this study are those suffering from these types of cancers. The importance of this study lies in its potential to provide a new treatment method for these conditions, which could improve patient care and address current challenges in treatment. Participants will have blood drawn to create CD19 CD28 chimeric receptor-T cells in a laboratory. These cells are then grown and frozen for later use. The process involves stimulating the blood with growth factors and using a special virus to attach the CD19 antibody to the T cells. Participants will receive these cells through an IV injection, which takes about 10 minutes. After the injection, they will be monitored in the clinic for up to 3 hours. Some participants may receive an additional injection of a drug called ipilimumab to help the T cells grow. Extra blood will be drawn to understand how the CD19 CD28 chimeric receptor-T cells work and how long they last in the body. The treatment will be given at the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.

Official TitlePhase I Study Of CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia
NCT00586391NCT00608270
Principal SponsorBaylor College of Medicine
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-CellDisease AttributesPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

1 inclusion criteria required to participate
Recurrent B cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation. If a patient is less than 18, the lymphoma/leukemia is highly aggressive (i.e. lymphoblastic, Burkitt, ALL)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group receive an intravenous injection of CD19CAR-28-zeta T cells, a type of genetic intervention. The dose level is assigned by the physician and can be repeated up to three extra times if clinical benefit is observed. Some patients may also receive Ipilimumab during the week 2 visit.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Houston Methodist Hospital

Houston, United StatesOpen Houston Methodist Hospital in Google Maps
Suspended

Texas Children's Hospital

Houston, United States
Suspended2 Study Centers