NCT05515185

Brief Summary

This is a clinical study to evaluate the safety and efficacy of CAR-T cells in the treatment of patients with advanced solid tumors in China.

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
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

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

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2024

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 23, 2022

Last Update Submit

August 23, 2022

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity

    DLT

    Up to 2 years

  • Maximum tolerable dose

    MTD

    Up to 2 years

Study Arms (1)

KT095 CAR-T

EXPERIMENTAL

KT095 CAR-T injection Intravenous infusion

Drug: KT095 CAR-T injection

Interventions

KT095 CAR-T injectionDRUG

Clearance of lymphocytes

Also known as: Fludarabine, Cyclophosphamide
KT095 CAR-T

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-70 and of both sexes;
  • Advanced solid tumor diagnosed by histology or pathology;
  • Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;
  • B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.
  • Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;
  • The ECOG score is 0-2, and the expected survival time is more than 12 weeks;
  • Laboratory test results should at least meet the following requirements:
  • Left ventricular ejection fraction ≥40%; Creatinine ≤200 umol/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L; Hemoglobin ≥80g/L; Oxygen saturation of blood 91%; Total bilirubin ≤2×ULN; ALT and AST 2.5 x ULN or less; The criteria for abnormal ALT and AST due to disease (e.g., liver metastases or bile duct obstruction) or Gilbert syndrome can be relaxed to ≤5×ULN.
  • Having venous access for blood collection or single blood collection;
  • The patient voluntarily participated and signed the informed consent in person.

You may not qualify if:

  • pregnant or lactating women;
  • Chemotherapy or radiotherapy was used within 3 days before the blood collection period;
  • Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids);
  • Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period;
  • Those who have used any gene or cell therapy products;
  • History of epilepsy or other central nervous system diseases;
  • Active hepatitis B or C virus, defined as: hepatitis B surface antigen HBsAg or hepatitis B core antibody HBcAb positive subjects with peripheral blood HBV DNA titer above the detection limit; HCV antibody positive for hepatitis C and HCV RNA positive in peripheral blood; People infected with HIV and syphilis;
  • Other tumors in the past 5 years;
  • Patients with severe chest and ascites;
  • There was active or uncontrollable infection requiring systemic treatment within 14 days before enrollment;
  • Other antineoplastic treatments (other than pretreatment and chemotherapy) were administered within 2 weeks before study initiation;
  • The investigator assessed that the patient was unable or unwilling to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222000, China

Location

MeSH Terms

Interventions

fludarabineCyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

xiaodong jiang, PhD

CONTACT

0518-85767557irb_lygyyy@163.com

Study Design

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

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

September 9, 2022

Primary Completion

September 8, 2024

Study Completion

September 8, 2024

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)