Study Details

Open

CD30 CAR-T cells for Hodgkin's/Non-Hodgkin's Lymphoma Trial

The purpose of this study is to establish a safe dose of study cells (ALTCAR.CD30) to give after chemotherapy and estimate progression free survival in pediatric patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) and non-Hodgkin lymphoma.

Age & Gender

3 years ~ 17 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

Your blood will be collected so the study team can begin to make the modified study cells. The study 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 study cells. If it is safe, you will complete three to four days of pre-treatment that will prepare your body to accept the study cells better. You will then receive the study cell infusion. You will have to stay near the hospital after infusion and will be seen frequently in the 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 13 visits through the first year, possibly more depending on side effects from treatment

Phone or online visits:
All visits are in person unless your disease gets worse, then you may be contracted by phone for follow ups

Total length of participation:
Treatment and initial follow-ups will last 1 year, long term follow-up will last for 15 years

Looking for Specific Volunteers

Able to participate:

You have Hodgkin's or non-Hodgkin's Lymphoma with cells positive for the CD30 marker
You have completed at least 2 prior therapies, but disease did not respond or the disease returned after treatment
Willing to stay close to UNC hospital systems for monitoring after treatment infusion
Hemoglobin >8 g/dL and transfusion independent

Not eligible if:

You are taking steroids (such as 10mg or more of prednisone)
You have active infection with HIV, HTLV, Hepatitis B or Hepatitis C
You have a tumor in a spot that could block your airway
Your disease becomes much worse prior to receiving the study cell infusion

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

UNC Immunotherapy
UNCImmunotherapy@med.unc.edu

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

Anne Beaven
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

16-0046

ClinicalTrials.gov

NCT02690545