CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04186520
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Central Nervous System Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone Lymphoma
  • Non Hodgkin Lymphoma (NHL)
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 8/12-Day Production of Car-T Cells — BIOLOGICAL
    A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.
  • 8/12-Day Production of Cryopreserved Car-T Cells — BIOLOGICAL
    A fixed cryopreserved dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.
  • 12-Day Production of Car-T Cells — BIOLOGICAL
    A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

Study Details

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.

Key Dates

Start date
May 18, 2020
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 8/12 Day Production of CAR-T for NHL
    Phase 1: Determine safety of 2.5x10\^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with relapsed, refractory B-cell NHL. Patients will be enrolled in 3+3 fashion. Phase 1b: Six to nine patient expansion cohorts at eight or 12-day manufacturing. If six patients are enrolled in Phase 1 then only six additional patients will be added. If three patients are enrolled in Phase 1 then nine additional patients will be treated for a total of 12 in each group.
  • Experimental: 8/12 Day Production of CAR-T for CLL
    Phase 1: Determine safety of 2.5x10\^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with CLL. Patients will be enrolled in 3+3 fashion. Phase 1b: The enrollment will cap at 24 subjects.
  • Experimental: 8/12 Flexible Manufacturing with Mandated Cryopreservation
    8/12 flexible manufacturing with mandated cryopreservation prior to infusion of LV20.19 CAR T-cells. The enrollment will cap at 24 subjects.
  • Experimental: 12-Day Production of Car-T Cells for NHL
    Phase 1: Determine safety of 2.5x10\^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with relapsed, refractory B-cell NHL. Patients will be enrolled in 3+3 fashion. Phase 1b: Six to nine patient expansion cohorts at 12-day manufacturing. If six patients are enrolled in Phase 1 then only six additional patients will be added. If three patients are enrolled in Phase 1 then nine additional patients will be treated for a total of 12 in each group.
  • Experimental: 8/12 Day Production of CAR-T for Relapsed/Refractory Primary or Secondary CNS Lymphoma
    Phase 1: Determine safety of 2.5x106 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with primary/secondary central nervous system (CNS) lymphoma. Phase 1b: Safety and efficacy will be evaluated in this study that will enroll 12 to 24 patients.
  • Experimental: Phase 2 - Efficacy of CAR-20/19-T cells in MCL
    Single-stage Phase II design with three-month CR as the target endpoint.

Primary Outcome Measure

Number of Adverse Events after CAR 20/19-T cell infusion [ Time Frame: Within the first 28 days after infusion ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of Wisconsin and Froedtert HospitalMilwaukeeWisconsin53226
Nirav Shah, MD
[email protected]

Find similar trials in Milwaukee, WI

By research site
Medical College of Wisconsin and Froedtert Hospital· Milwaukee, WI

Related Studies