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Advanced Solid TumorsPhase 1NCT05868915

HV-101 for Patients With Advanced Solid Tumors

A Phase 1 study testing HV-101 in people with Advanced Solid Tumors, run by Hervor Therapeutics at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Background: Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to treat patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HV-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteChina
Study dates
4 Aug 2023to 15 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.
  • Age ≥ 18 years and ≤ 75 years.
  • Expected survival time > 3 months.
  • ECOG score 0-1.
  • At least one lesion that could undergo surgery or biopsy to obtain tumor tissue for TIL preparation
  • At least 1 measurable lesion (according to RECIST v1.1).
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  • Metastatic or recurrent solid tumors confirmed by histopathology. Refractory to standard treatment evaluated by radiological assessment.
  • Hematology should at least meet the following criteria:
  • Absolute neutrophil count (ANC) ≥ 1.5× 109/L；
  • Platelet (PLT） ≥ 75× 109/L；
  • Hemoglobin (HGB) ≥ 90 g/L.
  • Liver and kidney function are normal:
  • Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min;
  • Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of ULN;
  • Total bilirubin (TBIL) ≤ 1.5 times of ULN.
  • Blood coagulation function is normal:
  • Prothrombin time (PT) ≤ 1.5 ULN;
  • International Normalized Ratio (INR) ≤ 1.5 ULN;
  • or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.
  • Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug.

Who cannot join

  • Under pregnancy or lactation, or positive based on blood pregnancy test.
  • Severe allergic to related ingredients in the clinical trial.
  • Received any other investigational treatment within 28 days before the administration of HV-101.
  • History of other known malignant tumors within the previous 5 years.
  • Primary central nerve system (CNS) cancer, or Participants with CNS metastasis after localized treatment.
  • Participants with any active autoimmune disease, a history of autoimmune disease, or a history or syndrome requiring treatment with systemic steroids or immunosuppressive drugs.
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  • Immunodeficiency including HIV positive, acquired or primary immunodeficiency.
  • Participants with ≥ grade 3 thromboembolic events within 6 months or under thrombolysis treatment.
  • Participants with hereditary or acquired hemorrhagic disease.
  • Participants with clinical cardiovascular disease or symptoms
  • Participants with active infection.
  • Participants with active pulmonary tuberculosis infection.
  • Participants with positive hepatitis B surface antigen or positive hepatitis B core antibody or positive hepatitis C virus antibody.
  • Treponema pallidum antibody positive.
  • Participants received major surgery or under severe injury within 28 days before HV-101 infusion.
  • Participants who received live vaccine or attenuated live vaccine 28 days before HV-101 infusion.
  • Participants who have drug addiction history, alcoholism, or drug users.
  • Participants who received cell therapy before enrollment.
  • Participants who have contraindications to the treatment of IL-2 injection.
  • Participants not suitable for the clinical trial evaluated by the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

Other trials in China

About this study

Official title: A Phase I/II Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of HV-101 Injection for the Patients With Recurrent or Metastatic Solid Tumors

Background:

Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to treat patients. TIL therapy has shown strong efficacy for the treatment of solid tumors, and has achieved high objective response rates in multiple cancers.

Read more

Objective:

To evaluate the safety and efficacy of HV-101 for the treatment of advanced solid tumors.

Eligibility:

Adults aging 18-75 with advanced solid tumors

Design:

  1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
  2. Freshly resected patient tumors were dissected by the surgeon.
  3. TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded.
  4. HV-101 will be re-infused into the patient.
Being tested
HV-101

What participants receive

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

  • HV-101Biological

    Biological: HV-101

    HV-101 is autologous tumor-infiltrating lymphocyte cells without genetic modification.

    Drug: IL-2

    Following cell infusion, the patient receives intravenous IL-2.

    Drug: Fludarabine

    Part of the non-myeloablative lymphocyte-depleting preparative regimen.

    Drug: Cyclophosphamide

    Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Study groups in NCT05868915
Study groupRoleWhat they receive
HV-101ExperimentalParticipants with Advanced Solid Tumors Interventions: Biological: HV-101 Drug: IL-2 Drug: Fludarabine Drug: Cyclophosphamide
Receives: Biological: HV-101

What is being measured

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

  1. Safety of HV-101

    The safety of HV-101 will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase.

    Measured: Day 0 - Day 730

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 as assessed by the investigator.

    Measured: Day 0 - Day 730

  2. Duration of Response (DOR)

    To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to any cause.

    Measured: Day 0 - Day 730

  3. Disease Control Rate (DCR)

    To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) per RECIST v1.1 as assessed by the investigator.

    Measured: Day 0 - Day 730

  4. Progression free survival (PFS)

    To evaluate the time from the date of HV-101 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause.

    Measured: Day 0 - Day 730

  5. Overall survival (OS)

    To evaluate the time from the date of HV-101 infusion to death due to any cause.

    Measured: Day 0 - Day 730

Timeline

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

  1. First posted22 May 2023
  2. Study start4 Aug 2023
  3. Primary completion31 May 2025
  4. Study completion15 Jan 2026

Why it stopped: Portfolio prioritization

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05868915
Sponsor's protocol ID
CV101
Status last verified
Jan 2026
First submitted
11 May 2023
Last updated
21 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HV-101 in people with Advanced Solid Tumors, run by Hervor Therapeutics 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 20 inclusion and 20 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: stopped early, as of the sponsor's last update on 21 Jan 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was stopped early (reason given: Portfolio prioritization). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of HV-101 (time frame: Day 0 - Day 730). 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 NCT05868915.

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 21 Jan 2026.

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