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CD19 CAR T-cells containing a Safety Switch to treat Relapsed /Refractoy Acute Lymphoblastic Leukemia

The purpose of this study is to establish a safe dose of study cells to give to patients with relapsed/ refractory ALL expressing CD19.

Age & Gender

  • 3 years ~ 70 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

Your blood will be collected to begin the manufacturing process to make the modified immune cells that will be the study treatment. The modified cells will hopefully be more effective at killing your cancer cells than your body's normal cells. The study team will do blood tests and other procedures to confirm it is safe for you to get the modified study cells. If it is safe, you will complete 3 days of pre-treatment chemotherapy, which will prepare your body to accept the study cells better. You will then receive the study cell infusion. Patients enrolled later in the study whose disease does not completely respond may be eligible to receive a 2nd round of chemotherapy and cell infusion. You will need to stay near the hospital after infusion and will be seen frequently in clinic for follow-up visits that may include lab tests, imaging, or biopsies of your tumor. You will continue follow up visits based on how well you have responded to the study treatment

In-person visits:
Minimum of 14 through first year of participation; likely more depending on side effects
Phone or online visits:
Visits all in person unless disease has worsened, then can be contacted by phone during follow up.
Total length of participation:
1 year for treatment and initial follow-up, long term follow-up for 15 years

Looking for Specific Volunteers

Able to participate:

  • You have been diagnosed with Acute Lymphoblastic Leukemia
  • You have relapsed or refractory disease after prior treatment
  • Leukemia cells must be positive for the C19 molecule
  • Willing to stay close to UNC after treatment and complete follow-up visits

Not eligible if:

  • You are taking corticosteroids at doses of 10 mg or more of prednisone
  • Active infection with HIV, HTLV, Hepatitis B or Hepatitis C, or other active infections
  • You have evidence of worsened heart function
  • Evidence that your leukemia has spread to your spinal cord or brain and you have neurological symptoms

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

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

Additional Study Information

Principal Investigator

Natalie Grover
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia)

IRB Number

16-1057

ClinicalTrials.gov

NCT03016377

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