Using HV-101 to treat advanced solid tumors

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

This study is testing a new treatment called HV-101 that uses the patient's own immune cells to see if it can help people with advanced solid tumors feel better and improve their treatment results.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hervor Therapeutics (Industry-sponsored)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05868915 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of HV-101, a form of tumor-infiltrating lymphocyte (TIL) therapy, for patients with advanced solid tumors. The approach involves harvesting lymphocytes from the patient's tumor, culturing and amplifying them in the lab, and then reinfusing them back into the patient. Eligible participants will undergo a series of screening tests to ensure they meet the criteria for the trial. The study aims to assess the potential of HV-101 to improve treatment outcomes for patients with refractory solid tumors.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with advanced solid tumors that have not responded to standard therapies.

Not a fit: Patients with early-stage tumors or those who are not eligible for tumor resection or biopsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard treatments.

How similar studies have performed: Previous studies utilizing TIL therapy have shown promising results in treating various solid tumors, indicating a potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.
2. Age ≥ 18 years and ≤ 75 years.
3. Expected survival time \> 3 months.
4. ECOG score 0-1.
5. At least one lesion that could undergo surgery or biopsy to obtain tumor tissue for TIL preparation
6. At least 1 measurable lesion (according to RECIST v1.1).
7. Metastatic or recurrent solid tumors confirmed by histopathology. Refractory to standard treatment evaluated by radiological assessment.
8. 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.
9. 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.
10. 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.
11. 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.

Exclusion Criteria:

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

Where this trial is running

Wuhan, Hubei

• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Qibin Song, Doctor

Conditions Advanced Solid Tumors