Study Details

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Phase Ib/II Study of ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells

Phase Ib: To evaluate the safety and tolerability of administration of ATLCAR.CD30.CCR4 cells in subjects with CD30+ Hodgkin's Lymphoma. 2.1.2 Phase II: To estimate the progression free survival (PFS) in adult subjects with Hodgkin's Lymphoma following lymphodepletion and infusion of ATLCAR.CD30.CCR4 cells.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

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

Location

North Carolina (Statewide)

What will be asked of you

The study involves blood draws,blood , test,biopsies,procedures,imaging/scanning and follow -up visits. you will donate your blood so study team can modify your cells to make the study treatment cells. The study treatment cells may be able to target cancerous cells better than the body's normal cells. The study team will do blood tests and other procedures to see if you are eligible to get the treatment cells. If you are eligible, you will complete three days of treatment that will prepare your body to accept the study treatment cells better. You will then return to the clinic for one day of study cell treatment. After treatment, you will have clinic visits for checkup tests and assessment including lab tests and imaging of your tumor. You will continue follow up visits based on how well you have responded to the study treatment.

Incentives

In-person visits:
Minimum of 14 through first year of participation

Total length of participation:
Total participation up to 15 years total

Looking for Specific Volunteers

Able to participate:

Subject must have a diagnosis of Classical Hodgkin Lymphoma by WHO criteria.
Diagnosis of recurrent lymphoma in subjects who have failed ≥ 2 prior treatment regimens
CD30+ disease documented by immunohistochemistry
Age ≥ 18 years at the time of consent

Not eligible if:

Subjects with history of intolerance to fludarabine or bendamustine will be excluded.
Subject is unwilling to undergo tumor biopsies
Subject has evidence of uncontrolled infection or sepsis.
Subjects using systemic corticosteroids at doses ≥10 mg prednisone daily
Subject does not have an ejection fraction of ≥ 35% as determined by echocardiogram

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

UNC Immunotherapy
UNCImmunotherapy@med.unc.edu

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
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

23-2771

ClinicalTrials.gov

NCT06090864