Actively Recruiting
Phase II Study of T Lymphocytes Expressing CD30 CAR for Relapsed/Refractory CD30+ Peripheral T Cell Lymphoma
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-09-22
20
Participants Needed
2
Research Sites
544 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of ATLCAR.CD30, a treatment using genetically modified T cells that target the CD30 antigen found on lymphoma cancer cells, in people with relapsed or refractory Peripheral T Cell Lymphoma. This phase II open-label trial involves participants whose T cells are collected and modified to produce a CD30 antibody, aiming to help the immune system attack the cancer. The study is sponsored by UNC Lineberger Comprehensive Cancer Center and includes patients who have undergone previous treatments. Participants receive two infusions of ATLCAR.CD30 cells, each preceded by lymphodepleting chemotherapy. The first lymphodepletion uses bendamustine and fludarabine, while the second uses cyclophosphamide and fludarabine, given 2 to 14 days before each infusion. If participants cannot tolerate bendamustine, an alternative regimen with cyclophosphamide and fludarabine is used before the first infusion. The ATLCAR.CD30 cells are infused intravenously over 5 to 10 minutes, with the volume depending on cell concentration and participant size. Participants may receive bridging standard-of-care therapy while their cells are being prepared. During the study, participants undergo blood sampling, imaging scans (CT or PET/CT), and various laboratory tests to monitor disease status and organ function. They will be followed for up to 15 years after treatment to assess long-term outcomes, including progression-free survival and overall survival. Safety is closely monitored, including potential side effects like infection, fever, neurotoxicity, and cytokine release syndrome. Clinic visits generally last between 1 to 8 hours, and participants may receive a second infusion if they show clinical benefit and meet eligibility for the second treatment phase.
CONDITIONS
Brief Title
CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of 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 if primary refractory or relapsed within 12 months including brentuximab vedotin unless ineligible
- Eligible if relapsed after autologous or allogeneic stem cell transplant with specific conditions
- Prior or concurrent malignancy allowed if it does not interfere with study
- Female participants of childbearing potential must have negative pregnancy test and agree to contraception
- Willing and able to comply with study procedures
You will not qualify if you...
- Pregnant or lactating individuals
- Current use of systemic corticosteroids at doses 10 mg prednisone daily or higher, unless approved by investigator
- Active infection with HIV, HTLV, or hepatitis C
- Positive hepatitis B surface antigen or detectable viral load
- Major surgery within 28 days prior to lymphodepletion
- Use of investigational agents or tumor vaccines within 6 weeks prior to lymphodepletion
- Anti-CD30 antibody therapy within 4 weeks prior to lymphodepletion
- Chemotherapy within 3 weeks prior to lymphodepletion
- Rapidly progressive disease by investigator judgment
- Use of strong CYP1A2 inhibitors if receiving bendamustine
- Taking prohibited or contraindicated medications prior to lymphodepletion
- Evidence of uncontrolled infection or sepsis prior to cell product administration
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to several weeks for cell collection and manufacturing
Participants provide blood samples or undergo leukapheresis to collect cells needed to manufacture the ATLCAR.CD30 treatment.
Up to 3 blood collection visits and possibly 1 leukapheresis session
Duration - Variable duration during cell manufacturing
Participants may receive standard of care chemotherapy or radiation as needed to stabilize their disease while ATLCAR.CD30 cells are being prepared.
Visits depend on bridging therapy schedule as determined by treating physician
Duration - Lymphodepletion 2 to 14 days before infusion; infusion over 5 to 10 minutes
Participants receive lymphodepleting chemotherapy with bendamustine and fludarabine (or cyclophosphamide and fludarabine if allergic to bendamustine) followed by the first infusion of ATLCAR.CD30 cells.
Approximately 4 visits (3 days of lymphodepletion plus infusion) over 1 to 2 weeks
Duration - Assessment at 8 weeks; second lymphodepletion and infusion 2 to 14 days prior to second infusion if eligible
Participants have disease assessed around Week 8 to determine eligibility for a second lymphodepleting chemotherapy and ATLCAR.CD30 infusion if they have stable disease, partial or complete response.
1 disease assessment visit and approximately 4 visits for lymphodepletion and second infusion if eligible
Duration - Up to 15 years
Participants are followed for safety, disease progression, and long-term outcomes for up to 15 years after the final cell infusion.
Visit schedule varies over time, including frequent early visits and long-term periodic follow-ups
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
S
Shamina Williams
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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