Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma

Summary

This study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma.

The investigators would like to target proteins that are expressed by these cells using the patient's own immune cells known as T lymphocytes.This research study uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes (CTLs), a new experimental therapy.

The proteins that investigators are targeting in this study are called tumor associated antigens (TAAs). These are cell proteins that are specific to the cancer cell.They either do not show or show up in low quantities on normal human cells. In this study the investigators are targeting five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol, patients have been treated and so far this treatment has shown to be safe.

Investigators now want to try this treatment in patients with multiple myeloma or if the investigators can arrest the progression of the patient's condition condition (described above) to multiple myeloma.

These TAA-specific CTLs are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn what the side effects are, and to see whether this therapy might help patients with multiple myeloma monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM)

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Conditions

• Multiple Myeloma

Interventions

BIOLOGICAL

TAA-specific CTLs

Groups A and B only: Each patient will receive 2 infusions at the same dose, 14 days apart, according to the following dosing schedules: Dose Level One: Day 0: 5 x 10\^6 cells/m2 and Day 14: 5 x 10\^6 cells/m2 Dose Level Two: Day 0: 1 x 10\^7 cells/m2 and Day 14: 1 x 10\^7 cells/m2 Dose Level Three: Day 0 2 x 10\^7 cells/m2 and Day 14 2 x 10\^7 cells/m2 If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion.

BIOLOGICAL

TAA-specific CTLs- fixed dose

Fixed dose of 2 infusions of 2 x 10\^7 cells/m2 administered 2 weeks apart. If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion.

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• Center for Cell and Gene Therapy, Baylor College of Medicine

  collaborator OTHER

• Harris County Hospital District

  collaborator OTHER_GOV

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Premal Lulla, MD · Baylor College of Medicine/Houston Methodist Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2026-12-31

Completion

2027-12-22

FDA Drug

Yes

Countries

• United States

Study Locations