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

NCT02291848 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: H-35626, TACTAM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief 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) .

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Cytotoxic T-lymphocytes

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Adverse events

  To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T-lymphocytes (CTL) in patients with Myeloma as well as those with high risk MGUS/Smoldering myeloma.

  8 weeks

Secondary Outcomes (3)

• Expansion of the CTLs

  1 year

• Persistence of the CTLs

  1 year

• Reduction of the Multiple Myeloma

  8 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Patients receiving TAA-specific CTLs as therapy for Myeloma

Biological: TAA-specific CTLs

Group B

EXPERIMENTAL

Patients receiving TAA-Specific CTLs as adjunctive therapy following autologous or syngeneic transplant for myeloma

Biological: TAA-specific CTLs

Group C

EXPERIMENTAL

Patients with high risk MGUS or smoldering myeloma receiving a fixed dose TAA-Specific CTLs

Biological: TAA-specific CTLs- fixed dose

Interventions

TAA-specific CTLs BIOLOGICAL

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.

Group A; Group B

TAA-specific CTLs- fixed dose BIOLOGICAL

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.

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient, at least 18 yrs old regardless of sex, with a diagnosis of high risk MGUS/smoldering myeloma or patients with a diagnosis of Multiple myeloma after receiving at least one treatment regimen OR
• Any patient, ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS (defined as have 2 of the following: 1. Non IgG MGUS, 2. M protein ≥ 1.5 g/dl, 3. Abnormal free light chain ratio (\<0.26 for lambda restricted disease or \>1.65 for kappa restricted disease) or a diagnosis of smoldering myeloma.
• Patients with life expectancy greater than or equal to 6 weeks.
• Hgb greater than or equal to 7.0 (transfusions allowed).
• Patient able to give informed consent.
• \- Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least one treatment regimen. If patient has received an autologous or syngeneic SCT they must be \>90 days post-transplant (Group A)
• Following autologous or syngeneic SCT (as adjuvant therapy) and \<90 days post transplant (Group B)
• Any patient ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS/Smoldering myeloma (definition of high risk MGUS/smoldering myeloma provided in protocol) (Group C)
• Patients with life expectancy greater than or equal to 6 weeks.
• Pulse oximetry of \>93% on room air in patients who previously received radiation therapy.
• Patients with a Karnofsky score of greater than or equal to 50.
• Patients with bilirubin less than or equal to 2 times upper limit of normal, AST less than or equal to 3 times upper limit of normal, and Hgb greater than or equal to 7.0 (transfusion allowed).
• Engrafted post transplant (ANC \>500) and ANC \>500 at the time of infusion if applicable.
• Patients with a creatinine less than or equal to 2x upper limit of normal for age.
• Patients should have been off other investigational therapy for one month prior to entry in this study.

You may not qualify if:

• Patients with severe active infection.
• Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
• Patients with severe active infection.
• Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
• Pregnant or breastfeeding

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator
• Harris County Hospital District: collaborator

Study Sites (3)

Harris Health Ben Taub Hospital

Houston, Texas, 77030, United States

RECRUITING

Harris Health Smith Clinic

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Premal Lulla, MD

  Baylor College of Medicine/Houston Methodist Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Premal Lulla, MD

CONTACT

832-824-4847; lulla@bcm.edu

Wendy Callejas

CONTACT

832-824-1538; wlcalle2@texaschildrens.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 17, 2014
• Study Start: April 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 22, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-01

Locations

US (3)