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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
John Lister
Study ID
NCT05281809
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Chimeric Antigen Receptor (CAR) T-Cell Product (Autologous) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 19, 2022
Status verified
Dec 2024
Primary completion
Aug 5, 2037
Completion
Dec 1, 2037

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    CAR -T-cell collection, infusion

Primary Outcome Measure

Successful local CAR T-cell manufacturing [ Time Frame: 48 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AHN Cancer Institute - West Penn HospitalPittsburghPennsylvania15224
John Lister, MD
[email protected]
4125784484
AHN Clinical Trials Contact
[email protected]
412-330-6011
Cyrus Khan, MD
Salman Fazal, MD
Anna Koget, DO
Prerna Mewawalla, MD
Santhosh Sadashiv, MD
Yazan Samhouri, MD
Thomas Curley, MD

Find similar trials in Pittsburgh, PA

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By specialty
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By research site
AHN Cancer Institute - West Penn Hospital· Pittsburgh, PA

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