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CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies

NCT02529813 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-06-30

No results posted yet for this study

Summary

This phase I clinical trial studies the side effects and best dose of CD19-specific T-cells in treating patients with lymphoid malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment. Sometimes researchers change the deoxyribonucleic acid (DNA) (genetic material in cells) of donated T-cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. Injecting modified T-cells made from the patient may help attack cancer cells in patients with advanced B-cell lymphoma or leukemia.

Conditions

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Tisagenlecleucel

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ziopharm Oncology

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Partow Kebriaei · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-16
Primary Completion
2021-11-08
Completion
2021-11-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02529813 on ClinicalTrials.gov