For Healthcare Professionals

Study of NIB101 in Participants With Advanced Solid Tumors

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About the study

NIB101-01 study is an open-label, non-randomized Phase 1 study in participants with GM2 positive advanced solid tumor, who failed to available standard of cares to evaluate the safety and tolerability of NIB101.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Participant with histologically or cytologically confirmed solid tumor.
  2. Participant who failed or are intolerable to available standard of cares (regardless of the number of prior lines of therapy) at the investigator's discretion.
  3. Participant whose tumor tissues express GM2 membrane as determined by immunohistochemistry.
  4. Participant who has measurable lesions.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  6. Life expectancy >=12 weeks from the signing screening ICF.
  7. Participant with adequate organ functions.
  8. Participant who can undergo apheresis at the investigator's discretion.
  9. Participant must agree to use adequate contraception methods
  10. Participant who is willing to sign a written informed consent.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Active brain metastasis on the screening MRI (in case of MRI contradiction, CT is acceptable)
  2. Participant with an active, known or suspected autoimmune disease requiring immune suppressive agents other than hormonal replacement therapy.
  3. Prior malignancy (other than targeted GM2 positive malignancy) within the previous 3 years the signing screening ICF.
  4. Suspected malignant lymphoma or leukemia
  5. Participant with known or suspected interstitial pneumonia
  6. Active infections requiring treatments
  7. Participant with an active, known or suspected gangliosidosis.
  8. Other concurrent serious diseases that may interfere with planned study intervention per investigator's discretion.
  9. Prior treatment with engineered T-cell therapy/gene therapy.
  10. Prior treatment with any GM2, Interleukin-7 (IL-7) or Chemokine (C-C motif) ligand 19 (CCL19) targeted therapy.
  11. Participant with a condition requiring systemic treatment with either corticosteroids (>= 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to apheresis. Inhaled or topical steroids, and adrenal replacement steroid doses <10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  12. Participant with adverse events due to prior therapy have not recovered to grade 1 or baseline, except for non-clinically significant adverse events at the investigator's discretion such as alopecia.
  13. Anti-neoplasm treatment within 14 days prior to apheresis
  14. Radiation therapy within 14 days prior to apheresis
  15. Participant currently requiring ganciclovir, valganciclovir, and so on (the drug that provides HSV-TK substrate) treatment. Participants currently receiving prophylaxis treatment can be enrolled if the prophylaxis treatment is completed before apheresis.
  16. Major surgery within 4 weeks prior to screening informed consent.
  17. Prior treatment with any investigational study drug/investigational study cell and gene therapies within 28 days before signing screening ICF.
  18. Positive human immunodeficiency virus (HIV) and/or Human T-cell leukemia virus-1 (HTLV-1) antibody test on the screening prior to apheresis.
  19. Positive Hepatitis B surface (HBs) antigen or Hepatitis C virus (HCV) antibody test on the screening prior to apheresis. Participant who has positive HBs antibody or Hepatitis B core (HBc) antibody can be enrolled if Hepatitis B virus (HBV)-DNA is undetectable.
  20. Any symptoms of suspected syphilis
  21. Pregnant or breastfeeding
  22. History of allergy or hypersensitivity to components of NIB101 or materials used for manufacturing NIB101.
  23. Hypersensitivity or contraindicated to study intervention components.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +81-3-5843-7819Email iconEmail Study Center

Study Details


Contition

Solid Tumor

Age

18+

Phase

PHASE1

Participants Needed

42

Est. Completion Date

Feb 29, 2028

Treatment Type

INTERVENTIONAL


Sponsor

Noile-Immune Biotech, Inc

ClinicalTrials.gov NCT Identifier

NCT05192174

Study Number

NIB101-01

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