Actively Recruiting
CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-09-22
20
Participants Needed
2
Research Sites
984 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. Blood samples will be collected from study participants and the immune T cells will be separated. T cells will be genetically modified in a laboratory at UNC-Chapel Hill to enable them to produce CD30 antibody. The modified T cells, called ATLCAR.CD30, will be able to target and attach to lymphoma cancer cells that carry the CD30 antigen. Once they are attached, the hope is that the T cells will attack and destroy the lymphoma cancer cells. To prepare the body for the ATLCAR.CD30 cells, participants will complete lymphodepletion with two chemotherapy agents. Lymphodepletion will happen over three days prior to ATLCAR.CD30 infusion. If participants respond to this treatment, and there are sufficient unused ATLCAR.CD 30 cells, they may be eligible to receive a second infusion. The second infusion will be given after a second lymphodepletion chemotherapy. Most of the clinic visits in this research will last between 1-8 hours. There are risks associated in participating in this research study. Risks of treatment include infection, fever, nausea, vomiting, neurotoxicity, and cytokine release syndrome which can include low blood pressure or difficulty breathing. Other risks are associated with study procedures, such as biopsies, imaging, infusion, and breach of confidentiality.
CONDITIONS
Official Title
CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization signed
- Age 18 years or older at consent
- Karnofsky score greater than 60%
- Histological or cytological confirmation of CD30+ peripheral T-cell lymphoma
- CD30+ disease confirmed by immunohistochemistry
- Received at least two prior lines of therapy, or one line with primary refractory or early relapse
- Eligible if relapsed after autologous or allogeneic stem cell transplant with conditions
- Prior or concurrent malignancy allowed if not interfering with study
- Female participants of childbearing potential must have negative pregnancy test within 72 hours prior to cell procurement
- Female participants of childbearing potential must use two forms of contraception or abstain from heterosexual activity during study and for 6 months after
- Willing and able to comply with study procedures
You will not qualify if you...
- Pregnant or lactating women
- Current use of systemic corticosteroids at doses 10 mg prednisone daily or higher (inhaled steroids allowed)
- Active infection with HIV, HTLV, or HCV
- Positive hepatitis B surface antigen or positive viral load if core antibody positive
- Life expectancy under 6 weeks
- Inadequate organ function or uncontrolled infection
- Major surgery within 28 days prior to lymphodepletion
- Recent investigational agents or tumor vaccines within 6 weeks prior to lymphodepletion
- Recent anti-CD30 antibody therapy within 4 weeks prior to lymphodepletion
- Recent chemotherapy within 3 weeks prior to lymphodepletion
- Rapidly progressive disease per investigator judgment
- Use of prohibited medications including strong CYP1A2 inhibitors with bendamustine
- Not a good candidate for CAR T-cell therapy as judged by investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
2
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
L
Lori Stravers
CONTACT
S
Shamina Williams
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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