Combination Immunotherapy Targeting Sarcomas

NCT04433221 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-20007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma; Osteoid Sarcoma; Ewing Sarcoma

Keywords

Sarcoma; Chemotherapy; Doxorubicin; CART; Vaccine

Outcome Measures

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

  3 months

Secondary Outcomes (2)

• Overall survival Rate

  1 year

• Treatment response rate of sarcomas

  1 year

Study Arms (1)

Multiple sarcoma-specific CAR-T cells

EXPERIMENTAL

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

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

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

Multiple sarcoma-specific CAR-T cells

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Confirmed malignant cell expression of CART target antigens by IHC or flow
• Karnofsky /jansky score of 50% or greater;
• Expected survival \> 8 weeks;
• ANC≥ 1×10\^6/L，PLT ≥ 1×10\^8/L;
• Pulse oximetry of≥90% 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Central Study Contacts

Lung-Ji Chang, Ph.D

CONTACT

+86 0755-86573763; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)