Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/Mem T-lymphocytes) for the Treatment of Central Nervous System Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05625594
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspiration — PROCEDURE
    Undergo CSF aspiration
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Catheterization — PROCEDURE
    Undergo catheterization
  • CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem T-lymphocytes — BIOLOGICAL
    Given ICV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Leukapheresis — PROCEDURE
    Undergo leukapheresis
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET

Study Details

This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with central nervous system (CNS) lymphoma. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid (which flows in and around the hollow spaces of the brain and spinal cord, and the thin layers of tissue that cover and protect the brain and spinal cord) in the brain, through a surgically placed catheter. Giving CD19-CAR T cells ICV may be more effective at treating patients with CNS lymphoma than giving them via other methods.

Key Dates

Start date
Jun 29, 2023
Status verified
Jun 2026
Primary completion
May 22, 2028
Completion
May 22, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (leukapheresis, CD19-CAR T cells)
    Patients may undergo catheterization, undergo leukapheresis, may receive fludarabine IV and cyclophosphamide IV, and receive CD19-CAR T cells ICV on study. Patients also undergo MRI, PET, CT, collection of blood samples, and CSF aspiration throughout the trial, and lumbar puncture as clinically indicated.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 15 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Tanya Siddiqi
[email protected]
626-803-3458
Tanya Siddiqi (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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