OncoMatch/Clinical Trials/NCT04083495
CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma
Is NCT04083495 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including ATLCAR.CD30 T cells and Bendamustine for peripheral t cell lymphoma.
Treatment: ATLCAR.CD30 T cells · Bendamustine · Fludarabine · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: TNFRSF8 positive (CD30+ by immunohistochemistry)
CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard.
Prior therapy
Must have received: anti-CD30 antibody-drug conjugate (brentuximab vedotin)
prior therapy included brentuximab vedotin unless they were not candidates for brentuximab vedotin
Must have received: autologous stem cell transplant
Subjects relapsed after autologous stem cell transplant are eligible for this study.
Must have received: allogeneic stem cell transplant
Subjects relapsed after allogeneic stem cell transplantation are eligible provided the patient is ≥180 days from transplant, not on immunosuppresive therapy to treat/prevent graft-versus-host disease and has no evidence of active graft-versus-host disease.
Lab requirements
Blood counts
Hemoglobin ≥8.0 g/dL (procurement); Absolute neutrophil count ≥ 1.0 × 10^9/L (lymphodepletion); Platelet count ≥ 50 × 10^9/L (lymphodepletion)
Kidney function
Creatinine ≤ 2 × ULN (procurement), ≤ 3 × ULN (lymphodepletion)
Liver function
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's Syndrome; AST ≤ 3 × ULN (procurement), ≤ 5 × ULN (lymphodepletion); ALT < 3 × ULN (procurement), ≤ 5 × ULN (lymphodepletion)
Subject has evidence of adequate organ function within 7 days of procurement as defined by: Hemoglobin ≥8.0 g/dL (transfusion is allowed prior to procurement); Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's Syndrome; AST ≤ 3 × ULN; ALT < 3 × ULN; Creatinine ≤ 2 × ULN; Pulse oximetry of >90% on room air. Subject must demonstrate adequate organ function prior to lymphodepletion as defined below. All tests must be obtained within 72 hours prior to lymphodepletion: Absolute neutrophil count ≥ 1.0 × 10^9/L; Platelet count ≥ 50 × 10^9/L; Total bilirubin < 2 x ULN unless attributed to Gilbert's syndrome; AST ≤ 5 x ULN; ALT ≤ 5 x ULN; Creatinine ≤ 3 x ULN; Pulse Oximetry of >90% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lineberger Comprehensive Cancer Center at University of North Carolina · Chapel Hill, North Carolina
- Wake Forest Baptist Medical Center · Winston-Salem, North Carolina
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