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HER2-positive Advanced Malignant Solid TumorsNCT06658951

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

A study testing Anti-HER2 CAR-T cells in people with HER2-positive Advanced Malignant Solid Tumors, run by UTC Therapeutics Inc. 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, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Anti-HER2 CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
3 Apr 2025to 30 Apr 2028
Phase
Interventional
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 18 to 70 years old (including cut-off value), gender is not limited.
  • 2. Solid tumors that histological diagnosis of malignancy refractory to, or relapsing after standard therapy, including but not limited to gastric cancer, biliary system tumors, bladder cancer, ovarian cancer, endometrial cancer, cervical cancer, colorectal cancer, breast cancer, lung cancer, esophageal cancer, etc.
  • 3. At least one measurable lesion according to RECIST v1.1.
  • 4. HER2 should be positive confirmed by Immunohistochemistry in tumor tissue samples.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 6. Life expectancy ≥ 3 months.
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  • 7. The organ function must meet the protocol requirements.
  • 8. Female participants of childbearing potential must undergo a pregnancy test and the results must be negative. Female participants of childbearing potential or male participants whose sex partner has childbearing potential must be willing to use effective methods of contraception from screening period to at least 1 year after infusion.
  • 9. Participants must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Who cannot join

  • 1. Pregnant or lactating women.
  • 2. Patients with hepatitis B surface antigen (HBsAg) positive. Patients who is hepatitis B core antibody (HBcAb) positive and the quantification of HBV DNA in peripheral blood is higher than the lower limit of detection. Patients who is hepatitis C virus (HCV) antibody positive and quantification of HCV DNA in peripheral blood is higher than the lower limit of detection. Patients with human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive.
  • 3. The toxicities caused by the prior therapy (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) have not recovered to grade 1 according to CTCAE, except for hair loss and peripheral sensory nerve disorders.
  • 4. Have received any allogeneic tissue/organ transplantation (including bone marrow transplantation, stem cell transplantation, liver transplantation, kidney transplantation), except for the transplantation that does not require immunosuppressive therapy (such as: corneal transplantation, hair transplantation.)
  • 5. Patients have received anti-HER2 CAR-T cell therapy.
  • 6. Patients who have history of major surgery and unrecovered severe trauma within 4 weeks prior to signing informed consent; or plan to have major surgery within 12 weeks of cell therapy.
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  • 7. Presence of known central nervous system metastases, but the following patients will be allowed: a) Asymptomatic brain metastases; b) Clinically stable (no radiographic progression within 4 weeks before apheresis and return of any neurologic symptoms to baseline), and with no need for corticosteroids or other treatment for brain metastases for ≥ 4 weeks.
  • 8. Patients with clinically significant systemic disease (such as: severe active infection or significant cardiac, pulmonary, hepatic, nervous system, or other organ dysfunction) that evaluated by the investigator would impair the patients' ability to tolerate the treatments used in this study or significantly increase the risk of complications.
  • 9. History of severe systemic hypersensitivity reaction to the drugs/ingredients [fludarabine, cyclophosphamide, dimethyl sulfoxide (DMSO), low molecular dextran, human serum albumin (HSA), etc.] used in this study.
  • 10. Patients have received attenuated vaccine within 4 weeks prior to signing informed consent.
  • 11. Patients have received other clinical trials within 4 weeks prior to signing informed consent.
  • 12. History of another malignancy tumor within the previous five years, except for adequately treated non-melanoma skin cancer, carcinoma in situ of bladder, stomach, colon, cervix/dysplasia, melanoma, or breast.
  • 13. History of neuropsychiatric diseases diagnosed by the ICD-11 criteria or evaluated by investigator, including but not limited to epilepsy, schizophrenia, dementia, drug and alcohol addictions.
  • 14. For any other reasons, the patients are believed not suitable for participation in this study by investigators.

Trial locations and contacts

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

Yi Zhang contact

15138928971

yizhang001@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Yi Zhang, 15138928971, yizhang001@163.com

    Recruiting

Other trials in China

About this study

Official title: Exploratory Study to Evaluate the Safety and Preliminary Efficacy of Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.

Read the detailed description

All eligible participants will receive a conditioning chemotherapy regimen of fludarabine, cyclophosphamide and ABRAXANE followed by Anti-HER2 CAR-T cell injection.The dose escalation phase will determine the maximum tolerated dose (MTD) of Anti-HER2 CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-HER2 CAR-T cell injection, and establish recommended phase 2 dose (RP2D).

Being tested
Anti-HER2 CAR-T cells
Keywords
Anti-HER2 CAR-T, Solid tumor

What participants receive

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

  • Anti-HER2 CAR-T cellsBiological

    All eligible participants will receive a conditioning chemotherapy regimen of fludarabine, cyclophosphamide and ABRAXANE followed by Anti-HER2 CAR-T cell injection.

Study groups in NCT06658951
Study groupRoleWhat they receive
Anti-HER2 CAR-T cellsExperimentalAll eligible participants will receive a conditioning chemotherapy regimen of fludarabine, cyclophosphamide and ABRAXANE followed by Anti-HER2 CAR-T cell injection.
Receives: Biological: Anti-HER2 CAR-T cells

What is being measured

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

  1. Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)

    Incidence and severity of dose-limiting toxicities (DLTs) following infusion of CAR-T cell injection, at each dose level tested in dose escalation phase.

    Measured: 4 weeks after the CAR-T cells infusion

  2. Adverse Events (AEs)

    Incidence and severity of adverse events.

    Measured: 2 years

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

    Measured: 2 years

  2. Disease Control Rate (DCR)

    Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

    Measured: 2 years

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from CAR-T infusion to the date of the disease progression or death from any cause.

    Measured: 2 years

  4. Overall Survival (OS)

    OS is defined as the time from CAR-T infusion to the date of death due to any cause.

    Measured: 2 years

Timeline

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

  1. First posted26 Oct 2024
  2. Study start3 Apr 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2028 (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
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Accelerated titration and 3+3 design dose escalation phase
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06658951
Sponsor's protocol ID
Anti-HER2 CAR-T
Status last verified
Mar 2026
First submitted
23 Oct 2024
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Anti-HER2 CAR-T cells in people with HER2-positive Advanced Malignant Solid Tumors, run by UTC Therapeutics Inc. 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 9 inclusion and 14 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 19 Mar 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.

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 Yi Zhang (15138928971, yizhang001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs) (time frame: 4 weeks after the CAR-T cells infusion). The study lists 2 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 NCT06658951.

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 19 Mar 2026.

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