Actively Recruiting
The Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed/Refractory CD30+ Hodgkin's Lymphoma
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-10-20
31
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hodgkin's Lymphoma (HL) remains a serious condition where over 15% of patients do not survive, and treatment side effects can be long-lasting. This research aims to evaluate ATLCAR.CD30.CCR4 cells, a new therapy targeting the CD30 antigen commonly found in HL, to determine the best dose and understand how well patients tolerate it. The study includes both phase Ib and phase II parts to explore safety and progression-free survival in patients with relapsed or refractory HL. Participants will receive one of three dose levels of ATLCAR.CD30.CCR4 cells using a 3+3 design. Before infusion, patients may undergo standard care bridging therapy while their cells are collected and processed. They will also receive lymphodepletion chemotherapy with bendamustine and fludarabine for three days before the cell infusion, which happens 2 to 14 days later. The study is open-label and conducted at a single center. During the study, participants will be closely monitored for adverse events including cytokine release syndrome and neurotoxicity for up to six weeks. The main outcome measures include safety, toxicity, and progression-free survival over six months. After treatment, patients will be followed for up to 15 years to observe long-term effects related to gene therapy. Various assessments and monitoring will occur throughout this time to evaluate overall survival and duration of response.
CONDITIONS
Brief Title
ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Be 18 years of age or older at the time of consent
- Have a Karnofsky performance score greater than 60%
- Have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria
You will not qualify if you...
- Had major surgery within the past 28 days
- Received investigational agents or tumor vaccines within the past 3 weeks
- Received chemotherapy or radiation therapy within the previous 3 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable, dependent on cell manufacturing time
During the time needed to manufacture the ATLCAR.CD30.CCR4 cells, participants may receive standard-of-care bridging therapy at their local oncologist's discretion.
Visits as needed depending on bridging therapy
Duration - Lymphodepletion chemotherapy for 3 consecutive days plus cell infusion 2 to 14 days later
Participants undergo lymphodepletion chemotherapy followed by infusion of ATLCAR.CD30.CCR4 cells.
Multiple visits over approximately 2 weeks including chemotherapy and cell infusion
Duration - Up to 15 years
Participants are monitored for safety and treatment effects including adverse events and progression for up to 6 months, with extended long-term follow-up for up to 15 years.
Regular visits for up to 6 months followed by long-term monitoring visits
Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Catherine Cheng
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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