ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    tactam
Previous Study | Return to List | Next Study

Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma (TACTAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02291848
Recruitment Status : Recruiting
First Posted : November 17, 2014
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Premal Lulla, Baylor College of Medicine

Brief Summary:

This study is for patients that have a cancer called Multiple Myeloma. 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 we target 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.

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: TAA-specific CTLs Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active Myeloma (TACTAM)
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Group A
Patients receiving TAA-specific CTLs as therapy for Myeloma
Biological: TAA-specific CTLs

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 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.


Experimental: Group B
Patients receiving TAA-Specific CTLs as adjunctive therapy following autologous or syngeneic transplant for myeloma
Biological: TAA-specific CTLs

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 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.





Primary Outcome Measures :
  1. Number of Patients with Adverse events [ Time Frame: 8 weeks ]
    To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T-lymphocytes (CTL) in patients with Myeloma.


Secondary Outcome Measures :
  1. Expansion of the CTLs [ Time Frame: 1 year ]
    Information on the expansion of the adoptively transferred tumor-specific CTL will be analyzed for the immunological parameters based on multimer analysis, intracellular cytokine staining and ELIspot assays to assess the frequency of cells secreting γ-IFN using the descriptive statistics such as mean, median, standard deviation at each time point.

  2. Persistence of the CTLs [ Time Frame: 1 year ]
    Information on the persistence of the adoptively transferred tumor-specific CTL will be analyzed for the immunological parameters based on multimer analysis, intracellular cytokine staining and ELIspot assays to assess the frequency of cells secreting γ-IFN using the descriptive statistics such as mean, median, standard deviation at each time point.

  3. Reduction of the Multiple Myeloma [ Time Frame: 8 weeks ]
    Comparison of diagnostic imaging studies from pre-infusion to 6 weeks following the second infusion will be summarized. Frequencies and proportions of responders will be summarized overall and by dose levels if there are enough patients per dose level.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Procurement Inclusion Criteria

  • Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least one treatment regimen.
  • Patients with life expectancy greater than or equal to 6 weeks.
  • Hgb >8.0 (transfusions allowed).
  • Patient able to give informed consent.

Treatment Inclusion Criteria

- 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) OR

Following autologous or syngeneic SCT (as adjuvant therapy) and <90 days post transplant (Group B)

  • 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 >8.0 (transfusion allowed).
  • Engrafted post transplant (ANC >500) and ANC >500 at the time of infusion.
  • 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.
  • Patients should have been off conventional therapy for at least 48 hours prior to entry in this study (except for lenalidomide, thalidomide, pomalidomide or immune checkpoint inhibitors such as CTLA4 and/or PD-1/PD-L1 inhibitors)
  • Patient able to give informed consent.
  • Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.

Procurement Exclusion Criteria

  • Patients with severe active infection.
  • Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).

Treatment Exclusion Criteria

  • Patients with severe active infection.
  • Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
  • Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291848


Contacts
Contact: Premal Lulla, MD 832-824-4847 lulla@bcm.edu
Contact: Munu Bilgi 832-824-1518 mxbilgi@txch.org

Locations
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Premal Lulla, MD    832-824-4847    lulla@bcm.edu   
Contact: Munu Bilgi    832-824-1518    mxbilgi@txch.org   
Sponsors and Collaborators
Baylor College of Medicine
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators
Principal Investigator: Premal Lulla, MD Baylor College of Medicine/Houston Methodist Hospital

Responsible Party: Premal Lulla, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02291848     History of Changes
Other Study ID Numbers: H-35626, TACTAM
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Premal Lulla, Baylor College of Medicine:
Multiple Myeloma
Cytotoxic T-lymphocytes

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases