Genetically Modified T Cells Treating Malignant Tumors

ConditionSolid Tumor

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorYi Zhang

About this trial

To observe the safety, tolerability and initial effectiveness of gene modified T cell therapy in patients with malignant tumors in First Affiliated Hospital of Zhengzhou University, China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with malignant tumors confirmed by histopathology or cytology, including: non-small cell lung cancer, esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, kidney cancer, cervical squamous cell carcinoma, ovarian cancer, breast cancer, melanoma, and brain glia tumor, lymphoma, etc.;

Age: 18 ~ 75 years old; Gender: no limitation;

Have sufficient hematopoietic capacity: ANC >1500 cells /mm3, Blood plate count >50,000 cells /mm3, HGB >9.0g/dL, ALC >9 cells /mm3;

Adequate liver and kidney function: AST and ALT ≤2.5 ULN in patients without liver metastasis and ≤5 times in patients with liver metastasis. ULN; Bilirubin ≤1.5 ULN (excluding hyperbilirubinemia or hyperbilirubin of non-hepatic origin); Creatinine ≤2.0 ULN. Creatinine clearance and creatinine clearance hormone ≥40 mL/min;

Disqualifiers

Received anti-PD1, anti-PD-L1 or anti-PD-L2 antibody therapy or other immunotherapy methods one month before treatment with immune cells in this study;

History of organ transplantation;

Pregnancy or lactation;

Positive for high baseline HBV DNA levels (≥2000 IU/ml), HIV antibodies (anti-HIV), hepatitis C virus antibodies (anti-HCV), or treponema pallidum antibodies;

Trial design

Design model

Single group

Treatments tested in this trial

CAR-T cell reinfusion
Biological/Vaccine
Subjects were identified according to their benefit from the first treatment and target expression Whether to accept multiple returns; CAR-T cell reinfusion dose was 1\~10×106 cells/kg, and the reinfusion dose could be adjusted according to the tolerance of the subjects Usually intravenous infusion, but also according to the need for local interventional treatment or injection treatment

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: subjectExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

PFS

Progression-Free-Survival (PFS) is defined as admission to the group according to imaging specialists based on RECIST 1.1 review when disease progression or death from any cause was first recorded, whichever came first.

Time frame

up to 36 months

Secondary outcomes

Overall survival (OS) is the time from enrollment to death from any cause

Time frame

up to 36 months

ORR

Objective response rate（ORR） refers to the proportion of subjects in the analysis population who achieved complete response (CR) or partial response (PR).

Time frame

up to 36 months

DOR

Duration of response (DOR). For subjects with confirmed CR or PR, duration of remission is the time from first recording to evidence of CR or PR until disease 2 progression (according to RECIST 1.1) or death from any cause, whichever occurs first.

Time frame

up to 36 months

Other outcomes

Quality of life improvement

EORTC QLQ C-30 survey

Time frame

Baseline,The first day of each course (before dosing),up to 4weeks .

Sponsors and contacts

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

Yi Zhang

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution

Source ClinicalTrials.gov

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