Health TrialsbyHealthPanel

Combination Immunotherapy Targeting Sarcomas

ConditionsSarcomaOsteoid SarcomaEwing Sarcoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-75
SponsorShenzhen Geno-Immune Medical Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage Ⅲ，Ⅳ 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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Multiple sarcoma-specific CAR-T cellsExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: