Study of NIB101 in Participants With Advanced Solid Tumors
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Participant with histologically or cytologically confirmed solid tumor.
- 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.
- Participant whose tumor tissues express GM2 membrane as determined by immunohistochemistry.
- Participant who has measurable lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy >=12 weeks from the signing screening ICF.
- Participant with adequate organ functions.
- Participant who can undergo apheresis at the investigator's discretion.
- Participant must agree to use adequate contraception methods
- Participant who is willing to sign a written informed consent.
EXCLUSION CRITERIA
Exclusion Criteria:
- Active brain metastasis on the screening MRI (in case of MRI contradiction, CT is acceptable)
- Participant with an active, known or suspected autoimmune disease requiring immune suppressive agents other than hormonal replacement therapy.
- Prior malignancy (other than targeted GM2 positive malignancy) within the previous 3 years the signing screening ICF.
- Suspected malignant lymphoma or leukemia
- Participant with known or suspected interstitial pneumonia
- Active infections requiring treatments
- Participant with an active, known or suspected gangliosidosis.
- Other concurrent serious diseases that may interfere with planned study intervention per investigator's discretion.
- Prior treatment with engineered T-cell therapy/gene therapy.
- Prior treatment with any GM2, Interleukin-7 (IL-7) or Chemokine (C-C motif) ligand 19 (CCL19) targeted therapy.
- 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.
- 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.
- Anti-neoplasm treatment within 14 days prior to apheresis
- Radiation therapy within 14 days prior to apheresis
- 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.
- Major surgery within 4 weeks prior to screening informed consent.
- Prior treatment with any investigational study drug/investigational study cell and gene therapies within 28 days before signing screening ICF.
- Positive human immunodeficiency virus (HIV) and/or Human T-cell leukemia virus-1 (HTLV-1) antibody test on the screening prior to apheresis.
- 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.
- Any symptoms of suspected syphilis
- Pregnant or breastfeeding
- History of allergy or hypersensitivity to components of NIB101 or materials used for manufacturing NIB101.
- Hypersensitivity or contraindicated to study intervention components.
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.
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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