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

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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) .

Key Dates

Start date

Apr 30, 2015

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 22, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Group A
  Patients receiving TAA-specific CTLs as therapy for Myeloma
• Experimental: Group B
  Patients receiving TAA-Specific CTLs as adjunctive therapy following autologous or syngeneic transplant for myeloma
• Experimental: Group C
  Patients with high risk MGUS or smoldering myeloma receiving a fixed dose TAA-Specific CTLs

Primary Outcome Measure

Number of Patients with Adverse events [ Time Frame: 8 weeks ]

Central Contacts

• Premal Lulla, MD
  832-824-4847
  [email protected]
• Wendy Callejas
  832-824-1538
  [email protected]

Locations (3)

Find similar trials in Houston, TX

Related Studies

• TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
  PHASE2 · Recruiting · American Society of Clinical Oncology · Birmingham, Alabama
• Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
  PHASE2 · Enrolling By Invitation · Autolus Limited · Miami, Florida
• Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
  PHASE1/PHASE2 · Recruiting · Regeneron Pharmaceuticals · Miami, Florida
• Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.
  PHASE1 · Recruiting · Newave Pharmaceutical Inc · Chicago, Illinois