HV-101 for Patients With Advanced Solid Tumors

NCT05868915 | Terminated Phase 1

• 1 other identifier: CV101
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. TIL therapy has shown strong efficacy for the treatment of solid tumors, and has achieved high objective response rates in multiple cancers. 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. 1.Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
2. 2.Freshly resected patient tumors were dissected by the surgeon.
3. 3.TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded.
4. 4.HV-101 will be re-infused into the patient.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (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.

  Day 0 - Day 730

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  Day 0 - Day 730

• Duration of Response (DOR)

  Day 0 - Day 730

• Disease Control Rate (DCR)

  Day 0 - Day 730

• Progression free survival (PFS)

  Day 0 - Day 730

• Overall survival (OS)

  Day 0 - Day 730

Study Arms (1)

HV-101

EXPERIMENTAL

Participants with Advanced Solid Tumors Interventions: Biological: HV-101 Drug: IL-2 Drug: Fludarabine Drug: Cyclophosphamide

Biological: HV-101

Interventions

HV-101 BIOLOGICAL

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.

HV-101

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hervor Therapeutics: lead
• Renmin Hospital of Wuhan University: collaborator

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: August 4, 2023
• Primary Completion: May 31, 2025
• Study Completion: January 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)