Study Details

Open

Phase II Study of CD30 CAR for relapsed/refractory CD30+ T Cell Lymphoma

To estimate the safety, effectiveness, and median progression free survival (PFS) after administration of the ATLCAR.CD30 (your immune cells modified in a specific way to target the disease) in subjects with relapsed/refractory CD30+ peripheral 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

United States (Nationwide)

What will be asked of you

After a consultation with the study team 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 you are eligible, 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 receive up to 2 infusions of the ATL.CAR.CD30. You will have to stay near the hospital after infusion and will be seen frequently in clinic for follow-up assessments 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

Incentives

$100 stipend to cover the cost of a hotel for the night prior to your cell infusion.

In-person visits:
Variable - based on disease and side effects

Phone or online visits:
Variable - based on worsened disease

Total length of participation:
Up to 15 years - this includes treatment, short-term follow up, and long-term follow up.

Looking for Specific Volunteers

Able to participate:

Confirmed diagnosis of peripheral T-cell lymphoma CD30 positive disease upon review of diagnostic tissue specimen; CD30+ must be confirmed by biopsy after recent therapy
Relapsed after two or more lines of treatment OR relapsed after first line of therapy within 12 months of completing chemotherapy (must include brentuximab vedotin)
Disease that is able to have response to treatment evaluated
Willingness to comply with study requirements (stay close to UNC after infusion, etc.)
Adequate performance status (ability to perform daily tasks) and organ function, based on specified laboratory results/parameters

Not eligible if:

Use of corticosteroids at doses of 10 mg or more of prednisone (or its equivalent)
Active infection with HIV, HTLV, Hepatitis B or Hepatitis C
Requirement for immunosuppressive therapy to treat graft-versus-host disease (GVHD) following allogeneic stem cell transplant OR < 180 days between allogeneic stem cell transplant and lymphodepletion
Rapidly worsening disease prior to cell infusion
Washout exclusions related to major surgery and prior therapy

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

Anne Beaven
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

19-1746

ClinicalTrials.gov

NCT04083495