NCT03356782 Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
| NCT ID | NCT03356782 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-06-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells 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 CAR T cells and IgT cells to treat sarcoma.
Eligibility Criteria
Inclusion Criteria: 1. Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients; 2. Age: ≥ 18 and ≤65 years of age at the time of enrollment; 3. At least 4 weeks since any chemotherapy or radiotherapy and at least 1 week since immunosuppressive therapy such as using steroid hormone before enrollment; 4. Side effects of chemotherapy have been well managed; 5. Malignant cells are target antigen positive(higher than ++) confirmed by IHC, quantitative PCR or sequencing; 6. Karnofsky /jansky score of 50% or greater; 7. Expected survival \> 6 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 autologous transduced T cells at levels greater than 15%; 13. Sign an informed consent and assent. Exclusion Criteria: 1. The disease is progresseing rapidly; 2. The patient is receiving therapy of other new drugs; 3. Evidence of tumor potentially causing airway obstruction; 4. Epilepsy history or other CNS diseases; 5. Patients who need immunosuppressive drugs because of GVAD; 6. History of long QT syndrome or severe heart diseases; 7. Uncontrolled active infection; 8. Active hepatitis B virus,hepatitis C virus and 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 would preclude participation as outlined; 13. Pregnant or lactating women; 14. Patients previously experienced toxicity from cyclophosphamide; 15. Patients who have CNS sarcoma; 16. In condition that may bring risks to subjects or interference to clinical trials.
Contact & Investigator
Lung-Ji Chang, PhD
PRINCIPAL INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Frequently Asked Questions
Who can join the NCT03356782 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 75 Years, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03356782 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03356782 currently recruiting?
Yes, NCT03356782 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT03356782 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT03356782 clinical trial?
NCT03356782 is sponsored by Shenzhen Geno-Immune Medical Institute. The principal investigator is Lung-Ji Chang, PhD at Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 20 participants.