Clinical trial · Interventional
TAA-Specific CTLS for Solid Tumors (TACTASOM)
Tumor Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes Administered to Patients With Solid Tumors
- 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 is a clinical trial for patients with a solid tumor which has come back, or may come back, or has not gone away after treatment, including the standard treatment we know for these diseases. This is a study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy. The proteins that the investigators are targeting in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells. In this study, the investigators target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different study, patients have been treated and so far this treatment has shown to be safe. The investigators now want to try this treatment in patients with solid tumors. This protocol is designed as a Phase I dose-escalation study.
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 |
|---|---|---|---|
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAA-Specific CTLs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAA-Specific CTLs
- description
- 4 different dosing schedules will be evaluated. 2 to 4 patients will be evaluated on each dosing schedule. The first 2 patients on each dose level will be staggered by 4 weeks (which starts when the first infusion is given, Day 0). No subjects between the ages of 2-18 will be enrolled to a dose level on this protocol, until an adult has been enrolled to and treated on that dose level on one of the protocols being conducted under this same IND. Each patient will receive 2 injections at the same dose,14 days apart: The expected volume of infusion will be 1 to 10 cc. Dose Level One: Day 0 and 14: 5 x 10\^6 cells/m\^2 Dose Level Two: Day 0 and 14: 1 x 10\^7 cells/m\^2 Dose Level Three: Day 0 and 14: 2 x 10\^7 cells/m\^2 Dose Level Four: Day 0 and 14: 4 x 10\^7 cells/m\^2
- interventionNames
- Biological: TAA-Specific CTLs
Primary outcomes (1)
- measure
- Number of patients with dose-limiting toxicity.
- timeFrame
- 8 weeks
- description
- The Phase I dose escalation trial is designed for the primary goal of evaluating the safety and feasibility of administering TAA-CTLs to patients with solid tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 80 Years
Show eligibility criteria text
THIS PROTOCOL IS CURRENTLY NOT RECRUITING ADULTS. Procurement Inclusion Criteria: 1. Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with: 1. Active disease after first line therapy; 2. Refractory disease; 3. As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years) 2. Patients with life expectancy at least 6 weeks. 3. Age greater than or equal to 2 and less than or equal to 80 years old. 4. Hgb \>8.0 5. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Procurement Exclusion Criteria: 1. Diagnosis of primary CNS tumor. 2. Patients with severe intercurrent infection. 3. Patients with active HIV infection at time of procurement (can be pending at the time of blood draw). 4. Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint. Treatment Inclusion Criteria: 1. Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with: 1. Active disease after first line therapy; 2. Refractory disease; 3. As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years) 2. Patients with life expectancy at least 6 weeks. 3. Age greater than or equal to 2 and less than or equal to 80 years old. 4. Pulse oximetry of \>95% on room air in patients who previously received radiation therapy. 5. Patients with a Karnofsky/Lansky score of greater than or equal to 50. 6. Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, and Hgb \>8.0 7. Patients with a creatinine less than or equal to 2x upper limit of normal for age. 8. Patients should have been off other investigational therapy for one month prior to entry in this study. 9. Patients should have been off conventional therapy for at least 1 week prior to entry in this study. PD1/PDL1 inhibitors will be allowed if medically indicated. 10. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. 11. 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. Treatment Exclusion Criteria: 1. Diagnosis of primary CNS tumor. 2. Patients with severe intercurrent infection. 3. Patients receiving systemic corticosteroids (patients off steroids for at least 48 hours are eligible). 4. Pregnant or breastfeeding 5. HIV positive. 6. Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint.
References
Publications (0)
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