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CD30 CAR T-cell therapy for Relapsed/Refractory CD30+ T Cell Lymphoma

This research study is testing a new treatment called ATLCAR.CD30 for people with Peripheral T Cell Lymphoma (a type of blood cancer) that has come back or isn't responding to other treatments and has the CD30 marker. The study aims to see how safe ATLCAR.CD30 is and if it helps. Your own immune T cells will be collected, modified in a lab to target CD30+ cancer cells, and then given back to you. Before receiving these cells, you'll get chemotherapy (Bendamustine and Fludarabine, or Cyclophosphamide and Fludarabine) to prepare your body. The study will measure how long you live without your cancer getting worse (progression-free survival) after 8 weeks. Up to 20 adults, aged 18 to 99, can join this study.

Study design
This is an open-label study, meaning both you and the study team will know what treatment you are receiving. It plans to enroll up to 20 participants.
What's involved
You will have blood samples collected, undergo chemotherapy for 3 days before each cell infusion, and receive two infusions of ATLCAR.CD30 cells. Your disease will be assessed at week 8 using CT or PET/CT scans.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured at 8 weeks after the ATLCAR.CD30 administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04083495

CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma

Recruiting
PHASE2Ages 18–99InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~20 participants
Updated 2025-09-22 on ClinicalTrials.gov
What's tested:ATLCAR.CD30 T cellsBendamustineFludarabineCyclophosphamide

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) after administration of the ATLCAR.CD30 in subjects with relapsed/refractory CD30+ peripheral T cell lymphoma
Measured over 8 weeks

Conditions

Peripheral T Cell Lymphoma

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NCT04083495

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Lineberger Comprehensive Cancer Center at University of North Carolina

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

  • Wake Forest Baptist Medical Center

    Winston-Salem, 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

  • Anne Beaven, MD · PRINCIPAL_INVESTIGATOR · UNC Chapel Hill

Who to contact

Lori Stravers
[email protected]
919-966-4432
Email the study team

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Eligibility criteria

Exclusion

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 x ULN
Creatinine ≤ 2 × ULN
Pulse oximetry of \>90% on room air 4. Imaging results from within 90 days prior to procurement to assess presence of active disease. 5. Negative serum pregnancy test within 72 hours prior to procurement or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for \>1 year, or documentation of surgical menopause (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
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 4. Subject must have available autologous transduced activated T cells product at a dose of 2x10\^8 cells/m\^2 and meets the Certificate of Analysis acceptance criteria. 5. No major surgery within 28 days prior to lymphodepletion. 6. Negative serum pregnancy test within 72 hours prior to lymphodepleting therapy for female participants of childbearing potential. Note: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. 7. Subject has not received any investigational agents or any tumor vaccines within the previous six weeks prior to lymphodepletion. 8. Subject has not received anti-CD30 antibody-based therapy within the previous 4 weeks prior to lymphodepletion. 9. Subject has not received chemotherapy within the previous 3 weeks prior to lymphodepletion. 10. Subject does not have rapidly progressive disease, per treating oncologist's discretion. 11. Subject is a good candidate for CAR T cell therapy, per treating oncologist's discretion. 12. Subjects on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2. (This applies to subjects who receive bendamustine for lymphodepletion (required) up through 72 hours after the last dose of bendamustine.) 13. Subject is not taking a prohibited or contraindicated medication prior to lymphodepletion. 14. Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \<10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed.
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's syndrome
AST ≤ 5 × ULN
ALT ≤ 5 × ULN
Creatinine ≤ 3 × ULN
Pulse Oximetry of \>90% on room air 4. Subject has no clinical indication of rapidly progressing disease in the opinion of the clinical investigator. 5. Subject is a good candidate for treatment with ATLCAR.CD30 cell product per the clinical investigator's discretion.
Absolute neutrophil count ≥ 1.0 × 10\^9/L
Platelet count ≥ 50 × 10\^9/L
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's syndrome
AST ≤ 5 × ULN
ALT ≤ 5 × ULN
Creatinine ≤ 3 × ULN
Pulse Oximetry of \>90% on room air 4. Subject must have available autologous transduced activated T cells product at a dose of 2x10\^8 cells/m\^2 and meets the Certificate of Analysis acceptance criteria. 5. Negative serum pregnancy test within 72 hours prior to lymphodepleting therapy for female participants of childbearing potential. Note: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. 6. Subject does not have evidence of uncontrolled infection or sepsis. 7. Subject is not receiving a prohibited medication at time of starting lymphodepletion up through 72 hours after the last dose of cyclophosphamide. 8. Subject is a good candidate for CAR T cell therapy, per treating oncologist's discretion. 9. Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \<10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed.
Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's syndrome
AST ≤ 5 × ULN
ALT ≤ 5 × ULN
Creatinine ≤ 3 × ULN
Pulse Oximetry of \>90% on room air 4. Subject has no clinical indication of rapidly progressing disease in the opinion of the clinical investigator. 5. Subject is a good candidate for treatment with ATLCAR.CD30 cell product per the clinical investigator's discretion.

What this trial measures

  • Progression free survival (PFS) after administration of the ATLCAR.CD30 in subjects with relapsed/refractory CD30+ peripheral T cell lymphoma8 weeks

    PFS is defined from day of initial lymphodepletion administration of the first ATLCAR.CD30 product infusion to the date of disease progression per the Revised Lugano Criteria or death as a result of any cause. Subjects who do not meet criteria for progression by the analysis data cut-off date will be censored at their last evaluable disease assessment date.