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CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description expanded, about 5 words
  2. Eligibility criteria expanded, about 1 wordv15
  3. Site contacts updated at 2 of 2 sitesv14
  4. Site contacts updated at 1 of 2 sitesv13
  5. 2 versions Re-verified since Apr 11, 2023, no change to tracked fieldsv11-v12
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Aug 2023 to Feb 23, 2028v10
  2. Eligibility criteria expanded, about 84 words
    • Study description expanded, about 136 words
    v9
  3. Primary completion date: Aug 2022 to Aug 2023
    • Study completion date: Aug 2037 to Aug 2038
    v8
  4. Site contacts updated at 1 of 2 sitesv7
  5. Study sites: 1 to 2v6
  6. Eligibility criteria revisedv5
  7. Primary completion date: Sep 2021 to Aug 2022v4 Show 6 more changesShow less
    • Study completion date: Sep 2034 to Aug 2037
    • Interventions: ATLCAR.CD30 T cells (Biological) to ATLCAR.CD30 T cells (Biological), Bendamustine (Drug), Cyclophosphamide (Drug), Fludarabine (Drug)
    • Eligibility criteria expanded, about 218 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 70 words
    • Site contact updated
  8. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  9. Secondary endpoints revised (6)
    • Study title shortened, about 4 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04083495
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Conditions
(from sponsor)		 Peripheral T Cell Lymphoma
Related terms Lymphoma, Lymphoma, T-Cell, Peripheral
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov