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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Sumithira Vasu
Study ID
NCT05418088
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • 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
  • Refactory Childhood Acute Lymphoblastic Leukemia
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory B-Cell Prolymphocytic Leukemia
  • Refractory Childhood Non-Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory High Grade B-Cell Lymphoma
  • Refractory Indolent Non-Hodgkin Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Transformed Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • Anti-CD19/CD20/CD22 CAR T-Cells — BIOLOGICAL
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine Phosphate — DRUG
    Given IV
  • Echocardiography — PROCEDURE
    Undergo echocardiography
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Pheresis — PROCEDURE
    Undergo apheresis
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Jun 30, 2022
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (lymphodepletion; anti-CD19/CD20/CD22 CAR-T cells)
    LYMPHODEPLETIVE REGIMEN: Patients receive cyclophosphamide IV over 60 minutes on day -6 and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. CAR T-CELL THERAPY: Patients receive anti-CD19/CD20/CD22 CAR-T cells IV over 5-30 minutes on day 0. Patients undergo ECHO or MUGA and may undergo tissue biopsy during screening, undergo apheresis on study, and undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
  • Experimental: Cohort B (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)
    LYMPHODEPLETIVE REGIMEN: Patients receive cyclophosphamide IV over 60 minutes on day -6 and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. CAR T-CELL THERAPY: Patients receive anti-CD19/CD20/CD22 CAR-T cells IV over 5-30 minutes on day 0 and 7. Patients undergo ECHO or MUGA and may undergo tissue biopsy during screening, undergo apheresis on study, and undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
  • Experimental: Cohort C (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)
    LYMPHODEPLETIVE REGIMEN: Patients receive cyclophosphamide IV on days -6 and -5 and fludarabine IV on days -6 to -3 in the absence of disease progression or unacceptable toxicity. CAR T-CELL THERAPY: Patients receive anti-CD19/CD20/CD22 CAR-T cells IV over 5-30 minutes on day 0 and 7. Patients undergo ECHO or MUGA and may undergo tissue biopsy during screening, undergo apheresis on study, and undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

Primary Outcome Measure

Recommended phase II dose of anti-CD19/CD20/CD22 CAR-T cells for each study group (Cohort A, Cohort B, and Cohort C) [ Time Frame: Up to 30 days after CAR T-cell infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43203
Kennedy Thompson
[email protected]
614-722-5043
Lori Jewell, BA
[email protected]
614-722-6576
Margaret Lamb, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Sumithira Vasu, MD
[email protected]
614-293-8197
Sumithira Vasu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Nationwide Children's Hospital· Columbus, OHOhio State University Comprehensive Cancer Center· Columbus, OH

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