Clinical trial · Interventional
Combination Immunotherapy Targeting Sarcomas
Safety and Efficacy Evaluation of a Combination Immunotherapy Targeting Sarcomas
NCT04433221CI-TRIAL-00123950not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Osteoid Sarcoma | Bone Neoplasm | PROBABILISTIC | 0.70 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple sarcoma-specific CAR-T cells and sarcoma vaccines | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multiple sarcoma-specific CAR-T cells
- description
- Patients who have confirmed surface antigens including GD2, PSMA, Her2, CD276 or other markers
- interventionNames
- Biological: Multiple sarcoma-specific CAR-T cells and sarcoma vaccines
Primary outcomes (1)
- measure
- Safety of CART cells infusion
- timeFrame
- 3 months
- description
- Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Secondary outcomes (2)
- measure
- Overall survival Rate
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage Ⅲ,Ⅳ sarcoma patients or recurrent sarcoma patients; 2. Age: ≥ 6 months and ≤80 years of age at the time of enrollment; 3. At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment; 4. Side effects of chemotherapy have been well managed; 5. Confirmed malignant cell expression of CART target antigens by IHC or flow 6. Karnofsky /jansky score of 50% or greater; 7. Expected survival \> 8 weeks; 8. ANC≥ 1×10\^6/L,PLT ≥ 1×10\^8/L; 9. Pulse oximetry of≥90% on room air; 10. Adequate hepatic function, defined as aspartate aminotransferase(AST)\< 5 times upper limit of normal(ULN),serum bilirubin \< 3 times ULN; 11. Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed; 12. Patients must have sufficient autologous CART cells at does greater than 0.5x10\^6 cells/kg body weight; 13. Sign an informed consent and assent. Exclusion Criteria: 1. The disease is progressing rapidly; 2. The patient is receiving therapy of other new drugs and under evaluation; 3. Evidence of tumor potentially causing airway obstruction; 4. Epilepsy history or other CNS diseases; 5. Patients who need immunosuppressive drugs; 6. History of long QT syndrome or severe heart diseases; 7. Uncontrolled active infection; 8. Active hepatitis B virus, hepatitis C virus or HIV infection; 9. Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids; 10. Previous treatment with any gene therapy; 11. Creatinine\>2.5mg/dl or ALT/AST\>3 times normal or bilirubin\>2.0 mg/dl; 12. Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined; 13. Pregnant or lactating women; 14. Patients previously experienced toxicity from cyclophosphamide and doxorubicin; 15. Patients who have CNS sarcoma; 16. In condition that may bring risks to subjects or interference to clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.