NCT04433221

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2020

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

June 9, 2020

Last Update Submit

June 12, 2020

Conditions

SarcomaOsteoid SarcomaEwing Sarcoma

Keywords

SarcomaChemotherapyDoxorubicinCARTVaccine

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 vaccinesBIOLOGICAL

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

Age1 Year - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

The Seventh Affilliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, 518107, China

RECRUITING

MeSH Terms

Conditions

SarcomaBone NeoplasmsSarcoma, Ewing

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBone DiseasesMusculoskeletal DiseasesOsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective Tissue

Central Study Contacts

Lung-Ji Chang, MD

CONTACT

86-(0755)86725195c@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, 2020

Primary Completion

May 31, 2023

Study Completion

December 31, 2023

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)