Combination Immunotherapy Targeting Sarcomas

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Shenzhen Geno-Immune Medical Institute
Updated on 19 February 2024
renal function
sarcoma
immunosuppression
immunosuppressive agents
steroid hormone
immunosuppressive
kidney function tests
serum bilirubin level
pulse oximetry
creatinine clearance rate
recurrent sarcoma

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.

Description

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.

Details
Condition Connective and Soft Tissue Neoplasm, Solid Tumors, Ewing's sarcoma, Osteosarcoma, Osteosarcoma, Sarcoma, Sarcoma, Solid Tumors
Age 1-75 years
Treatment Multiple sarcoma-specific CAR-T cells and sarcoma vaccines
Clinical Study IdentifierNCT04433221
SponsorShenzhen Geno-Immune Medical Institute
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Stage sarcoma patients or recurrent sarcoma patients
Age: 6 months and 80 years of age at the time of enrollment
At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment
Side effects of chemotherapy have been well managed
Confirmed malignant cell expression of CART target antigens by IHC or flow
Karnofsky /jansky score of 50% or greater
Expected survival > 8 weeks
ANC 110^6/LPLT 110^8/L
Pulse oximetry of90% on room air
Adequate hepatic function, defined as aspartate aminotransferase(AST)< 5 times upper limit of normal(ULN),serum bilirubin < 3 times ULN
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
Patients must have sufficient autologous CART cells at does greater than 0.5x10^6 cells/kg body weight
Sign an informed consent and assent

Exclusion Criteria

The disease is progressing rapidly
The patient is receiving therapy of other new drugs and under evaluation
Evidence of tumor potentially causing airway obstruction
Epilepsy history or other CNS diseases
Patients who need immunosuppressive drugs
History of long QT syndrome or severe heart diseases
Uncontrolled active infection
Active hepatitis B virus, hepatitis C virus or HIV infection
Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids
Previous treatment with any gene therapy
Creatinine>2.5mg/dl or ALT/AST>3 times normal or bilirubin>2.0 mg/dl
Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined
Pregnant or lactating women
Patients previously experienced toxicity from cyclophosphamide and doxorubicin
Patients who have CNS sarcoma
In condition that may bring risks to subjects or interference to clinical trials
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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