ATLCAR.CD30.CCR4 for Relapsed/Refractory Hodgkin Lymphoma
This study is testing a new cell therapy called ATLCAR.CD30.CCR4 for people with Hodgkin Lymphoma that has come back (relapsed) or hasn't responded to other treatments (refractory). Hodgkin Lymphoma can be very serious, and new treatments are needed to improve outcomes and reduce side effects. This therapy uses your own immune cells, called T-cells, which are specially modified to target a protein called CD30 found on most Hodgkin Lymphoma cells. Before receiving the ATLCAR.CD30.CCR4 cells, you would get a short course of chemotherapy with bendamustine and fludarabine. The main goal of this study is to see how well people tolerate the ATLCAR.CD30.CCR4 cells and to find the best dose. This study is open to adults aged 18 and older.
- Study design
- This is an interventional study with a planned enrollment of 31 participants. The phase of the study is not specified, and the status is currently unclear.
- What's involved
- You would receive chemotherapy with bendamustine and fludarabine for three days, followed by the ATLCAR.CD30.CCR4 cell infusion. You may also receive standard-of-care therapy to stabilize your disease during cell preparation.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure side effects like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) for up to 6 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
At a glance
Conditions
NCT06090864
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Natalie Grover, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase 1b adverse eventsUp to 6 weeks
Toxicity will be graded as the number of participants with adverse events (AE) related to the administration of ATLCAR.CD30.CCR4 cells in subjects with CD30+ Hodgkin's Lymphoma. AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Dose Limiting Toxicities (DLTs) are defined as at least possibly related to CAR.B7-H3T cell product administration.
- Phase 1b Toxicity Cytokine Release Syndrome (CRS)Up to 6 weeks
CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading related to the administration of ATLCAR.CD30.CCR4 cells in subjects with CD30+ Hodgkin's Lymphoma. Grade 1 - Mild: Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate: Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe: Fever ≥ 38\^ o C, Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening: Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death
- Phase 1b Toxicity Immune effector cell-associated neurotoxicity syndrome (ICANS)Up to 6 weeks
Neurotoxicity will be graded according to the Immune effector cell-associated neurotoxicity syndrome (ICANS) criteria related to the administration of ATLCAR.CD30.CCR4 cells in subjects with CD30+ Hodgkin's Lymphoma. Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).
- Phase II Median Progression Free Survival (PFS)Up to 6 months
Median PFS will be measured from the first day of lymphodepletion chemotherapy prior to ATLCAR.CD30.CCR4 cell infusion to progression (as defined by Lugano Criteria or death. Complete: Complete metabolic response on Positron emission tomography (PET) or the largest transverse diameter (LDi) of target nodes/masses ≤ 1.5 cm and no extra lymphatic disease on Computerized Tomography (CT). Partial: reduced uptake compared with baseline and residual mass(es) on PET and ≥50% decrease in the sum of the products of diameters (SPD) of nodes and extranodal sites on CT. No Response or Stable Disease: No metabolic response on PET or \< 50% decrease from baseline in SPD, measurable nodes and extranodal sites; no criteria for the progressive disease are met on CT. Progressive Disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new focus on PET, LDi\>1.5 cm or by ≥ 50% from nadir.