Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT01318317
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo autologous PBSCT
  • Filgrastim — BIOLOGICAL
    Given IV
  • Genetically Engineered Lymphocyte Therapy — BIOLOGICAL
    Receive ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo autologous PBSCT
  • Plerixafor — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.

Key Dates

Start date
Sep 19, 2011
Status verified
Apr 2026
Primary completion
Oct 3, 2013
Completion
Feb 24, 2027

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cellular adoptive immunotherapy following PBSCT)
    Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with G-CSF and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Within 28 days of T-cell infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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

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