Study Details

Open

Study of CAR-T cells in relapsed/refractory Hodgkin's Lymphoma and Cutaneous T-Cell Lymphoma

The purpose of this study is to establish a safe dose of study cells (ATLCAR.CD30.CCR4 and ATLCAR.CD30) to give to patients with CD30+ refractory/relapsed Hodgkin's Lymphoma and Cutaneous T-Cell Lymphoma.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

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

Location

North Carolina (Statewide)

What will be asked of you

Your blood will be collected so the manufacturing process to make the modified study treatment cells can begin. The modified 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 modified 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 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 visits for the first year, possibly more depending on site effects of treatment

Phone or online visits:
All visits will be done in clinic unless your disease gets worse. Then you might complete follow-up visits by phone.

Total length of participation:
1 year for treatment and initial follow-up visits, long term follow-up for 15 years

Looking for Specific Volunteers

Able to participate:

You have one of the following diseases: classic Hodgkin's Lymphoma, Mycosis fungoides, Sezary syndrome, Primary cutaneous lymphoproliferative disorder, Grey zone lymphoma
You have completed and failed 2 or more prior treatments. These treatments must include brentuximab vedotin.
If you have Hodgkin's Lymphoma, you must have failed autologous transplant or not be eligible to autologous transplant
Your cancer cells are positive for CD30 marker
Willing to stay close to UNC after treatment and complete follow-up visits

Not eligible if:

You are using corticosteroids at doses of 10 mg or more of prednisone (or its equivalent)
You have active infection with HIV, HTLV, Hepatitis B or Hepatitis C
You have a history of having bad side effects related to the drug fludarabine
You have abnormal results from ECG
Your tumor is in a location where enlargement could cause airway obstruction

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

Natalie Grover
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

18-0224

ClinicalTrials.gov

NCT03602157