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Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia

NCT05281809 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-13

No results posted yet for this study

Summary

This trial aims to demonstrate the feasibility of this approach to reliably generate product and to safely administer the product to patients who have B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.

Conditions

Interventions

DRUG

Chimeric Antigen Receptor (CAR) T-Cell Product (Autologous)

This protocol describes the use of an automated cell processor and culture system, the CliniMACS Prodigy device sold by Miltenyi Biotec, for the local manufacture of CAR T-cells targeting the CD19 antigen. The manufacturing process will use a lentiviral vector (CAR19) provided by Lentigen, a wholly owned subsidiary of Miltenyi Biotec, to transfect T-cells collected from eligible patients. Live cells will be harvested by the device after culture and infused intravenously to the patient from whom the cells were originally obtained.

Sponsors & Collaborators

  • Lentigen Technology, Inc.

    collaborator UNKNOWN

  • Miltenyi Biotec, Inc.

    collaborator INDUSTRY

  • Allegheny Health Network

    collaborator OTHER

  • John Lister

    lead OTHER

Principal Investigators

  • John Lister, MD · AHN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2037-08-05
Completion
2037-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05281809 on ClinicalTrials.gov