Study Details

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Gene Therapy Study for CD19 Positive Hematologic Malignancies

The main purpose of this study is to test the safety of a gene therapy. Scientists have created a gene in the laboratory that could be transferred to the cells in the body. This gene carries information to tell the cells how to make an antibody (protein). The antibody (protein) is very similar to an antibody (protein) called blinatumomab. Blinatumomab is an FDA-approved treatment for relapsed or refractory B-cell ALL. This gene therapy is not approved by the FDA, therefore is it experimental. This study tests different doses of the gene therapy to see which dose is safer in people since it has not been tested in people yet.

Age & Gender

13 years ~ 90 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

The study will begin with screening evaluations to determine if you are eligible to receive the study drug. If you are eligible, you will receive an intravenous (IV) or oral (by mouth) steroid over several days before the study drug infusion to control adverse reactions. You will then receive a single dose of the study drug directly into your vein. The steroid will continue for several days after your infusion as well. You will be monitored after the study drug infusion and be required to stay one of two nights in the hospital/clinic for observation. You will be asked to visit the study doctor weekly for 56 days for safety observation. During this time, blood tests will be performed twice per week. One of these weekly blood tests can be performed near you or you may choose to go to the study site for this blood collection. Follow up for this study will last 15 years. You will be followed approximately monthly, every 2 months, every 4 months, and every 6 months for 4 years, then yearly for years 5-15 (which may include a phone call follow-up by your study doctor/study staff years 6-15).

Incentives

Reimbursements for the efforts associated with study participation (including reasonable costs of meals and travel required to participate in this study) will be available

In-person visits:
Approximately 28 for the first 5 years

Phone or online visits:
Approximately 10

Total length of participation:
Up to 15 years after dose of study drug (this includes treatment and follow up)

Looking for Specific Volunteers

Able to participate:

Have Relapsed and/or Refractory CD19 Hematologic Malignancy (as defined per protocol)
You are able to consent and comply with study requirements
You meet prior therapy and/or washout requirements
You have adequate organ function as defined by the protocol

Not eligible if:

You are at high risks for adverse events
Infection of other severe systemic disease or condition that in the opinion of the Investigator could adversely affect your safety
Are unable to commit to a highly effective contraception during the study and at least 60 month after study drug infusion

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Immunotherapy Team
UNCImmunotherapy@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Lacey Williams
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia, Lymphoma)

IRB Number

25-0753

ClinicalTrials.gov

NCT06533579