Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07239323

In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies

Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-11-20

24

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors. It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.

CONDITIONS

Official Title

In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Confirmed diagnosis of relapsed or refractory malignant hematological tumors including B-ALL, B-cell lymphoma, or multiple myeloma
  • ECOG performance status score between 0 and 2 with expected survival of at least 3 months
  • Blood tests during screening must show hemoglobin ≥ 6 g/dL (without recent transfusion), absolute neutrophil count ≥ 600/µL, platelet count ≥ 50,000/µL, and lymphocyte count ≥ 500/µL
  • Normal kidney function with creatinine clearance rate ≥ 45 mL/min
  • Liver function within limits: ALT and AST ≤ 3 times upper limit, total bilirubin ≤ 2 times upper limit (with some exceptions)
  • Heart function with left ventricular ejection fraction ≥ 40%, no significant pericardial effusion or ECG abnormalities
  • Pulmonary function with blood oxygen saturation ≥ 90%
  • Women of childbearing age must test negative for pregnancy and not be breastfeeding
  • Men and women of childbearing potential must use effective contraception and not donate reproductive cells during and for 1 year after the study
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Received chemotherapy, targeted therapy, or immunotherapy within 5 half-lives before treatment
  • Received radiotherapy within 4 weeks before treatment (unless small bone marrow area involved)
  • Hematopoietic stem cell transplantation within 3 months before treatment
  • History of other active malignant tumors within 2 years or untreated non-melanoma skin cancer
  • Previous treatment with vesicular stomatitis virus glycoprotein pseudotyped virus
  • Severe or uncontrolled infections during screening
  • Significant cardiac diseases such as symptomatic heart failure, severe arrhythmia, recent heart attack or surgery, or severe cardiomyopathy
  • Other serious diseases including primary immunodeficiency, recent stroke or seizure, dementia, Parkinson's disease or related disorders
  • Surgery within 2 weeks before or planned within 2 weeks after treatment (except local anesthesia)
  • Live attenuated vaccine received within 1 month before treatment
  • History of severe allergic reactions to this therapy or its components
  • Unsuitable for establishing intravenous access
  • Any other condition deemed by the investigator as unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Kunming, Yunnan, China

Actively Recruiting

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Research Team

W

Wang Sanbin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies | DecenTrialz