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Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary completion pushed from Jul 1, 2026 to Jul 1, 2027v9
  2. Primary completion date: Apr 30, 2026 to Jul 1, 2026
    • Study completion date: Jul 31, 2026 to Jul 1, 2027
    v8
  3. Primary completion date: Apr 30, 2025 to Apr 30, 2026v7
  4. Enrollment target: 36 to 54v6 Show 6 more changesShow less
    • Primary endpoint revised
    • Interventions: Anti-CD19/CD20/CD22 CAR T-Cells (Biological), Cyclophosphamide (Drug), Fludarabine Phosphate (Drug) to Anti-CD19/CD20/CD22 CAR T-Cells (Biological), Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy…
    • Eligibility criteria expanded, about 46 words
    • Study description expanded, about 144 words
    • Site contacts updated at 1 of 2 sites
    • Study arms: 2 to 3
  5. Primary completion date: Dec 31, 2024 to Apr 30, 2025
    • Study completion date: Dec 31, 2024 to Jul 31, 2026
    • Eligibility criteria expanded, about 46 words
    • Collaborators expanded, about 4 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study sites: 1 to 2
    v4
  2. Start date changed from estimate of Jul 31, 2022 to Jun 30, 2022v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 1, 2022 to Jul 31, 2022
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sumithira Vasu
3 trials monitored
See 1 trial at risk
Leukemia
2,948 trials monitored
See 180 trials at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
Acute Lymphoblastic Leukemia (ALL)
931 trials monitored
See 58 trials at risk
and 1 more disease
This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.
Trial Details
NCT Number NCT05418088
Lead Sponsor Sumithira Vasu
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia, Recurrent B-Cell Prolymphocytic Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent High Grade B-Cell Lymphoma, Recurrent Indolent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Transformed Chronic Lymphocytic Leukemia +10 more
Related terms Burkitt Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, B-Cell, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov