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Advanced Malignant TumoursEarly Phase 1NCT07395479

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

A Early Phase 1 study testing V001-BCMA, V001-GPRC5D and V001-DLL3 in people with Advanced Malignant Tumours, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Tumours
What is being tested?
V001-BCMA, V001-GPRC5D and V001-DLL3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
21 Nov 2025to Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Ning, M.D. contact

+86 01087788165

lining@cicams.ac.cn

Shuhang Wang, PhD contact

+86 01087788165

wangshuhang@cicams.ac.cn

China1 site, 1 recruiting

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

    Beijing, Beijing Municipality, 100021

    Ning Li, +86010-87788165, lining@cicams.ac.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
V001-BCMA, V001-GPRC5D, V001-DLL3, V001-FcRH5
Keywords
in vivo CAR-T, DLL3, GPRC5D, BCMA, FcRH5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V001-BCMAGenetic

    An in vivo CAR-T drug targeting BCMA administered intravenously

  • V001-GPRC5DGenetic

    An in vivo CAR-T drug targeting GPRC5D administered intravenously

  • V001-DLL3Genetic

    An in vivo CAR-T drug targeting DLL3 administered intravenously

  • V001-FcRH5Genetic

    An in vivo CAR-T drug targeting FcRH5 administered intravenously

Study groups in NCT07395479
Study groupRoleWhat they receive
V001-BCMAExperimentalIntravenous administration of V001-BCMA as a single agent for patients with B-cell-related hematologic malignancies. Dose cohorts: 1x10^8 TU、2x10^8 TU、≤4x10^8 TU and ≤8x10^8 TU.
Receives: Genetic: V001-BCMA
V001-GPRC5DExperimentalIntravenous administration of V001-GPRC5D as a single agent for patients with B-cell-related hematologic malignancies. Dose cohorts: 1x10^8 TU、2x10^8 TU、≤4x10^8 TU and ≤8x10^8 TU.
Receives: Genetic: V001-GPRC5D
V001-DLL3ExperimentalIntravenous administration of V001-BCMA as a single agent for patients with small cell lung cancer. Dose cohorts: 1x10^8 TU、2x10^8 TU、≤4x10^8 TU and ≤8x10^8 TU.
Receives: Genetic: V001-DLL3
V001-FcRH5ExperimentalIntravenous administration of V001-FcRH5 as a single agent for patients with B-cell-related hematologic malignancies. Dose cohorts: 1x10^8 TU、2x10^8 TU、≤4x10^8 TU and ≤8x10^8 TU.
Receives: Genetic: V001-FcRH5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 28 days post-infusion.

    Measured: Within 28 days after the first infusion

  2. Maximum Tolerated Dose (MTD)

    To determine the MTD of V001 Injection.

    Measured: During the dose-escalation phase (approximately 12 months)

  3. Incidence of Adverse Events (AEs)

    Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.

    Measured: From signing ICF until 24 months after the last infusion.

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    Best overall response rate assessed per indication-specific criteria.

    Measured: At Day 28, Months 2, 3, 6, 9, 12, 18, 24 post-infusion

  2. Duration of Response (DOR)

    Time from first achieving response to disease progression or death.

    Measured: 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

  3. Progression-Free Survival (PFS)

    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

    Measured: 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

  4. Overall Survival (OS)

    Time from infusion to death from any cause

    Measured: From the date of infusion until the date of death from any cause, assessed up to 24 months

  5. Peak concentration of CAR-T cells in peripheral blood

    Peak concentration of CAR-T cells in peripheral blood

    Measured: At multiple timepoints post-infusion up to Month 24

  6. time to peak of CAR-T cells in peripheral blood

    time to peak of CAR-T cells in peripheral blood

    Measured: At multiple timepoints post-infusion up to Month 24

  7. AUC of CAR-T cells in peripheral blood

    AUC of CAR-T cells in peripheral blood

    Measured: At multiple timepoints post-infusion up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start21 Nov 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395479
Sponsor's protocol ID
NCC5276
Status last verified
Feb 2026
First submitted
10 Jan 2026
Last updated
13 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing V001-BCMA, V001-GPRC5D and V001-DLL3 in people with Advanced Malignant Tumours, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Ning, M.D. (+86 01087788165, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Within 28 days after the first infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07395479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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