Menu
Recruiting NCT07395479

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

Early Phase I Interventional Advanced Malignant Tumours

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: V001-BCMA, V001-GPRC5D, V001-DLL3, V001-FcRH5.
Who it may be relevant to
Registry conditions: Advanced Malignant Tumours. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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, etc.) based on a lentiviral vector platform in patients with advanced malignant tumors (including hematological malignancies and solid tumors). The study employs a platform design, enrolling patients into different cohorts based on target and indication.

Interventions

  • Genetic V001-BCMA
    An in vivo CAR-T drug targeting BCMA administered intravenously
  • Genetic V001-GPRC5D
    An in vivo CAR-T drug targeting GPRC5D administered intravenously
  • Genetic V001-DLL3
    An in vivo CAR-T drug targeting DLL3 administered intravenously
  • Genetic V001-FcRH5
    An in vivo CAR-T drug targeting FcRH5 administered intravenously

Primary outcome measures

  • Incidence of Dose-Limiting Toxicities (DLTs) [Time frame: Within 28 days after the first infusion]
  • Maximum Tolerated Dose (MTD) [Time frame: During the dose-escalation phase (approximately 12 months)]
  • Incidence of Adverse Events (AEs) [Time frame: From signing ICF until 24 months after the last infusion.]
Secondary outcome measures (7)
  • Objective Response Rate (ORR) [Time frame: At Day 28, Months 2, 3, 6, 9, 12, 18, 24 post-infusion]
  • Duration of Response (DOR) [Time frame: From date of the first response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]
  • Progression-Free Survival (PFS) [Time frame: From date of infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]
  • Overall Survival (OS) [Time frame: From the date of infusion until the date of death from any cause, assessed up to 24 months]
  • Peak concentration of CAR-T cells in peripheral blood [Time frame: At multiple timepoints post-infusion up to Month 24]
  • time to peak of CAR-T cells in peripheral blood [Time frame: At multiple timepoints post-infusion up to Month 24]
  • AUC of CAR-T cells in peripheral blood [Time frame: At multiple timepoints post-infusion up to Month 24]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years.
  • Histologically confirmed advanced hematological malignancies (e.g., multiple myeloma, lymphoma) or solid tumors (e.g., small cell lung cancer) that are relapsed or refractory.
  • Tumor cells express the relevant target (e.g., BCMA, GPRC5D, DLL3) as required for the specific cohort.
  • ECOG performance status 0-2 (hematological malignancies) or 0-1 (solid tumors) and life expectancy ≥ 3 months.
  • Adequate organ function (e.g., creatinine clearance ≥45 mL/min, LVEF ≥45%).
  • Patients of childbearing potential must agree to use effective contraception during the study and for 1 year after dosing.
  • Signed informed consent form.

Exclusion criteria

  • Active, uncontrolled infection.
  • Active central nervous system metastases or involvement.
  • Prior anticancer therapy, radiotherapy, or investigational therapy within specified timeframes before the first study dose.
  • Severe cardiac or pulmonary disease (e.g., NYHA Class III/IV heart failure), severe hepatic or renal impairment.
  • Active Hepatitis B, Hepatitis C, HIV, or syphilis infection.
  • Prior allogeneic hematopoietic stem cell transplantation (within specified window) or active graft-versus-host disease.
  • Pregnancy or lactation.
  • History of severe allergy to any components of the investigational product.
  • Any other condition deemed by the investigator to increase risk or interfere with study results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District — Beijing

Identifiers

NCT: NCT07395479 · NCC5276

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗