Using immune cells to target cancer in multiple myeloma patients

Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active Myeloma (TACTAM)

This study is testing if using patients' own immune cells can help fight cancer in people with multiple myeloma and related conditions.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 3 sites (Houston, Texas and 2 other locations)
• Trial ID: NCT02291848 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on patients with multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), or smoldering myeloma. The study aims to utilize the patient's own immune cells, specifically tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes (CTLs), to target and destroy cancer cells expressing specific proteins. Blood will be collected to grow and train these T cells to recognize and attack the cancer cells. Patients will receive infusions of these specially prepared T cells, with their disease progression monitored throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with high-risk MGUS, smoldering myeloma, or multiple myeloma who have undergone at least one treatment regimen.

Not a fit: Patients with low-risk MGUS or those who have not received any prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with multiple myeloma and related conditions.

How similar studies have performed: Other studies utilizing T cell therapies for cancer treatment have shown promising results, indicating potential success for this approach.

Eligibility criteria

Procurement Inclusion Criteria

* 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.

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)

OR

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.
* 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

Where this trial is running

Houston, Texas and 2 other locations

• Harris Health Ben Taub Hospital — Houston, Texas, United States (Recruiting)
• Harris Health Smith Clinic — Houston, Texas, United States (Recruiting)
• Houston Methodist Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Premal Lulla, MD — Baylor College of Medicine/Houston Methodist Hospital
• Study coordinator: Premal Lulla, MD

Conditions Multiple Myeloma; Cytotoxic T-lymphocytes