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Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas

Study acronym: CABAL2
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 24 words Site details revised at 2 of 2 sites Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  2. Study description expanded, about 30 wordsv10 See this version in full on ClinicalTrials.gov ↗
  3. Primary endpoint revised Eligibility criteria revised · Study description shortened, about 541 wordsv9 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study description shortened, about 541 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 1, 2028 to Jul 27, 2028 · Completion date: Jun 1, 2043 to Jun 27, 2043 · Start date changed from estimate of Oct 1, 2025 to Oct 27, 2025 · 1 morev8 Show 4 more changesShow less
    • Primary completion date: Jul 1, 2028 to Jul 27, 2028
    • Completion date: Jun 1, 2043 to Jun 27, 2043
    • Start date changed from estimate of Oct 1, 2025 to Oct 27, 2025
    • Site details revised at 2 of 2 sites
  5. Study description revisedv7 See this version in full on ClinicalTrials.gov ↗
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  1. Start date: May 1, 2025 to Oct 1, 2025v6
  2. Study description expanded, about 22 wordsv5 See this version in full on ClinicalTrials.gov ↗
  3. Start date: Jan 1, 2025 to May 1, 2025v4
  4. Eligibility criteria expanded, about 16 words Study description expanded, about 8 wordsv3 Show 1 more changeShow less
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Jun 1, 2024 to Jan 1, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment. Previous research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells. Another study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date. In this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma. As an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.
Trial Details
NCT Number NCT06176690
Lead Sponsor Baylor College of Medicine
Collaborators: The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, Anaplastic Large Cell Lymphoma, ALK-Positive, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative, Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov