Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07395479

A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-05-13

50

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single-arm, open-label, single-center, dose-escalation Phase I platform study designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of an in vivo CAR-T therapy (V001 Injection, targeting BCMA, GPRC5D, DLL3,FcRH5, etc.) in patients with advanced malignant tumors.

CONDITIONS

Official Title

A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed advanced blood cancers (e.g., multiple myeloma, lymphoma) or solid tumors (e.g., small cell lung cancer) that have returned or did not respond to treatment
  • Tumor cells must express the relevant target (e.g., BCMA, GPRC5D, DLL3) for the specific study group
  • ECOG performance status 0 to 2 for blood cancers or 0 to 1 for solid tumors, with life expectancy of at least 3 months
  • Adequate organ function, including creatinine clearance of 45 mL/min or higher and left ventricular ejection fraction of 45% or higher
  • Patients able and willing to use effective contraception during the study and for 1 year after treatment if of childbearing potential
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Active, uncontrolled infection
  • Active central nervous system metastases or involvement
  • Prior anticancer treatment, radiotherapy, or investigational therapy within specified timeframes before first study dose
  • Severe heart or lung disease (e.g., NYHA Class III/IV heart failure), severe liver or kidney impairment
  • Active infection with Hepatitis B, Hepatitis C, HIV, or syphilis
  • Prior allogeneic hematopoietic stem cell transplant within specified time or active graft-versus-host disease
  • Pregnancy or breastfeeding
  • History of severe allergy to any components of the investigational treatment
  • Any other condition that the investigator believes may increase risk or interfere with study results

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

Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

L

Li Ning, M.D.

CONTACT

S

Shuhang Wang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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