Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Recruiting
Phase 1Phase 2Interventional Study
SarcomaOsteoid SarcomaEwing Sarcoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Shenzhen Geno-Immune Medical Institute · Other
Who this trial is looking for
This trial is looking for adults with advanced or recurrent sarcoma. Participants will receive a type of immunotherapy called CAR T cells to see how well it works and what side effects it may have.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with stage 3 or stage 4 sarcoma.
I am between 18 and 65 years old.
I have not received chemotherapy or radiotherapy in the last 4 weeks.
I have not taken immunosuppressive therapy in the last week.
My cancer cells have specific markers that can be targeted.
I have a Karnofsky score of 50% or more.
I expect to live for more than 6 weeks.
I have enough healthy blood cells and my oxygen levels are good.
You may not be able to join if
My disease is getting worse quickly.
I am taking other new cancer treatments.
I have a history of central nervous system diseases.
I have uncontrolled active infections.
I am pregnant or breastfeeding.
I have a history of serious heart problems.
I have had toxicity from cyclophosphamide in the past.
I have active infections like hepatitis or HIV.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 enrollmen…
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.
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