Clinical trial · Interventional
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active Myeloma (TACTAM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAA-specific CTLs | Biological | — | UNRESOLVED |
| TAA-specific CTLs- fixed dose | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Patients receiving TAA-specific CTLs as therapy for Myeloma
- interventionNames
- Biological: TAA-specific CTLs
- type
- EXPERIMENTAL
- label
- Group B
- description
- Patients receiving TAA-Specific CTLs as adjunctive therapy following autologous or syngeneic transplant for myeloma
- interventionNames
- Biological: TAA-specific CTLs
- type
- EXPERIMENTAL
- label
- Group C
- description
- Patients with high risk MGUS or smoldering myeloma receiving a fixed dose TAA-Specific CTLs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available