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Not yet recruitingNCT04433221Updated Aug 26, 2026

Combination Immunotherapy Targeting Sarcomas

A Phase 1/2 interventional study of Multiple sarcoma-specific CAR-T cells and sarcoma vaccines in Sarcoma, Osteoid Sarcoma and Ewing Sarcoma, sponsored by Shenzhen Geno-Immune Medical Institute. Not yet recruiting at 1 site in China. Open to participants aged 1 Year to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Shenzhen Geno-Immune Medical Institute · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

Important Regulatory Notice:

This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.

ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.

Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy. Therefore, innovative interventions are needed. Sarcoma is known to express increased levels of surface antigens that can be targeted by CAR-T cells. In addition, studies have shown that low dose chemotherapy such as doxorubicin may modulate surface PD-L1 level and enhance immunotherapy effects. This study will combine multiple CAR T cells with low dose chemotherapy to treat sarcoma, and followed by maintenance sarcoma vaccines. The purpose of this clinical trial will assess the feasibility, safety, efficacy and side effects of this combination therapy in patients who have sarcoma that is relapsed or late staged.

02

Conditions studied

  • Sarcoma
  • Osteoid Sarcoma
  • Ewing Sarcoma

Keywords

  • Sarcoma
  • Chemotherapy
  • Doxorubicin
  • CART
  • Vaccine
03

Who can participate

Ages eligible
1 Year to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Multiple sarcoma-specific CAR-T cells

    Patients who have confirmed surface antigens including GD2, PSMA, Her2, CD276 or other markers

    Biological: Multiple sarcoma-specific CAR-T cells and sarcoma vaccines

Interventions

  • BiologicalMultiple sarcoma-specific CAR-T cells and sarcoma vaccines

    1 infusion, CART 1x10\^6\~1x10\^7 cells/kg via IV and vaccines 1-5x10\^6 irradiated cells via subcutaneous injection

05

What researchers measure

Primary outcomes

  1. Safety of CART cells infusion

    Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

    Time frame: 3 months

Secondary outcomes

  1. Overall survival Rate

    Percentage of participants with objective response as determined by the investigator based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

    Time frame: 1 year

  2. Treatment response rate of sarcomas

    Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on CT imaging analysis.

    Time frame: 1 year

06

Study locations

1 site
  • Shenzhen Geno-Immune Medical Institute
    Shenzhen, Guangdong 518000, China
    • Lung-Ji Chang, ph.D · Contact · c@szgimi.org · +86-13671121909
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04433221
Lead sponsor
Shenzhen Geno-Immune Medical Institute
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
Jul 1, 2027 (estimated)
Primary completion
May 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Aug 26, 2026

Study contacts

Lung-Ji Chang, Ph.D
Contact
c@szgimi.org
+86 0755-86573763

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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