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A clinical trial of allogeneic ?dt cell infusion to improve the immune function of patients with advanced cancer

A clinical trial of allogeneic ?dt cell infusion to improve the immune function of patients with advanced cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086398
Enrollment
Unknown
Registered
2024-07-01
Start date
2023-05-26
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Interventions

Experimental group:(1) the patients were selected and treated with ?dt cell infusion for 4 times. The interval of each infusion was 7 days, and the dose of each infusion was 1 × 109 cells According to

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 714/2000 1) patients aged 18-80 years without gender limitation, 2) patients with advanced tumor diagnosed by pathology and imaging, who were rated as C by PG-SGA, 3) patients who had received second-line or above therapy before, 4) expected survival time =3 months, 5) laboratory parameters: A. The criteria of blood routine examination were: HB =70g/l (no blood transfusion within 14 days) , ANC =1.5 × 109/l, PLT =80 × 109/l, lymphocyte (LY)=0.7 × 109/l, LY% =15% , ALB =28G/L, serum lipase and amylase & LT; 1.5 × ULN (upper limit of normal) ;. Biochemical tests were required to meet the following criteria: Tbil =1.5 × ULN (upper limit of normal) ; ALT and AST =2.5 × ULN; ALT and AST =5 × ULN if liver metastases were present; serum CR =2.5 × ULN, endogenous creatinine clearance > GT; 50 ml/min (Cockcroft-gault formula) ; 6) adequate comprehension and voluntary informed consent to participate in clinical studies; 7) women of reproductive age with negative pregnancy tests or male patients who had to use effective and reliable methods of contraception up to 30 days after the end of treatment during the study.

Exclusion criteria

Exclusion criteria: 701/2000 Patients with severe coronary artery disease or pulmonary insufficiency who have hypertension that can not be controlled with medication, unstable heart failure (uncontrolled arrhythmia, unstable angina) , uncompensated congestive heart failure, myocardial infarction within 6 months, current or previous history of brain metastasis or central nervous system invasion, severe active viral or bacterial infection that can not be controlled with treatment, HBV or HCV infection that is serologically positive for HIV or syphilis and is not controlled, immune-related diseases such as autoimmune disease, organ transplantation, or long-term use of immunosuppressive drug such as glucocorticoid, pregnant or lactating women, and any other serious illness that the researchers believe may affect the treatment, follow-up, or evaluation of the patient. It includes any clinically significant neurological, psychiatric, immunomodulatory, metabolic and infectious diseases that have not been controlled, and 9) patients who are not suitable for immune cell therapy after clinical diagnosis and evaluation

Design outcomes

Primary

MeasureTime frame
immune function check;quality of life;

Secondary

MeasureTime frame
1) PG-SGA score;objective response rate (ORR) ;tumor markers;median progression-free survival (PFS);median overall survival (OS);

Countries

China

Contacts

Public ContactXiao Liang

Shenzhen Second People's Hospital

9179320@qq.com+86 135 5476 4527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026