Genetically Modified T Cells Treating Malignant Tumors

NCT06515626 | Recruiting Early Phase 1

• 1 other identifier: YiZhang
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor

Keywords

CAR

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 36 months

Secondary Outcomes (3)

• OS

  up to 36 months

• ORR

  up to 36 months

• DOR

  up to 36 months

Other Outcomes (1)

• Quality of life improvement

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

Study Arms (1)

subject

EXPERIMENTAL

Biological: CAR-T cell reinfusion

Interventions

CAR-T cell reinfusion BIOLOGICAL

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

subject

Eligibility Criteria

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

You may qualify if:

• 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;
• PT/INR \<1.5 ULN, and PTT/αPTT \<1.5 ULN;
• For desirable tumor tissues or tissue white tablets, positive expression of at least one of Mesothelin, NKG2D, HER2, CD276, CD19, BCMA and other antigens can be selected for clinical trials;
• ECOG physical status score 0 \~ 2 points;
• Expected survival \>6 months;
• Subject accepts voluntarily

You may not qualify if:

• 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;
• There is active infection;
• There are active brain metastases (except asymptomatic or stable brain metastases after treatment);
• Combined with a second tumor; With the exception of patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid cancer who achieved complete response to the second tumor for more than 5 years and did not require treatment during the study period;
• Severe autoimmune diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener's granulomatosis require long-term (more than 2 months) systemic immunosuppressive therapy;
• People with allergies;
• NYHA heart failure grade ≥2 or hypertension can not be controlled after standard treatment, have a history of myocarditis or have a heart attack within one year;
• Thrombotic diseases with active bleeding that require treatment;
• Patients who are determined by the researcher to have a serious uncontrollable disease or other conditions that may affect the treatment in this study and are considered unsuitable.

Sponsors & Collaborators

• Yi Zhang: lead

Study Sites (1)

Zhengzhou University First Affiliated Hospital

Zhengzhou, Henan, China

RECRUITING

Study Officials

• Yi Zhang, MD

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Central Study Contacts

Yi Zhang, MD

CONTACT

+86 15138928971; yizhang@zzu.edu.cn

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 INVESTIGATOR
• PI Title: M.D. &; Ph.D. Director, Biotherapy Center Co-Director, Division of Scientific Research Distinguished Professor, Cancer Center The First Affiliated Hospital of Zhengzhou University

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 23, 2024
• Study Start: August 18, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CN (1)