Study of NIB101 in Participants With Advanced Solid Tumors
An Open-Label Non-Randomized Phase 1 Dose Escalation and Dose Expansion Study of NIB101 in Participants With Advanced Solid Tumors
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Clinical Trial Information Contact
- Phone Number: +81-3-5843-7819
- Email: dev@noile-immune.com
Study Locations
-
-
Chiba
-
Kashiwa, Chiba, Japan
- National Cancer Center Hospital East
-
-
Tokyo
-
Chuo Ku, Tokyo, Japan
- National Cancer Center Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: NIB101 Dose Level 1
1 x 10^7 cells/body as chimeric antigen receptor (CAR) positive viable cells will be administered intravenously on Day 0.
|
NIB101
|
|
Experimental: NIB101 Dose Level 2
1 x 10^8 cells/body as CAR positive viable cells will be administered intravenously on Day 0.
|
NIB101
|
|
Experimental: NIB101 Expansion Cohort
Recommended dose determined on dose escalation phase will be administered intravenously on Day 0.
|
NIB101
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dose Limiting Toxicities
Time Frame: 28 days after NIB101 infusion
|
Specific adverse events defined in the protocol and related to NIB101 infusion
|
28 days after NIB101 infusion
|
|
Adverse Events
Time Frame: 2 years from NIB101 infusion
|
Number of participants with adverse events
|
2 years from NIB101 infusion
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response
Time Frame: 2 years from NIB101 infusion
|
Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) determined by the investigator per RECIST version 1.1 or modified RECIST
|
2 years from NIB101 infusion
|
|
Overall Response Rate
Time Frame: 2 years from NIB101 infusion
|
Percentage of subjects who achieved PR or better
|
2 years from NIB101 infusion
|
|
Disease Control Rate
Time Frame: 2 years from NIB101 infusion
|
Percentage of subjects who achieved SD or better
|
2 years from NIB101 infusion
|
|
Duration of Response
Time Frame: 2 years from NIB101 infusion
|
Time from first documentation of response (PR or better) to first documentation of disease progression or death from any cause
|
2 years from NIB101 infusion
|
|
Time To Response
Time Frame: 2 years from NIB101 infusion
|
Time from NIB101 infusion to the initial documented response (PR or better)
|
2 years from NIB101 infusion
|
|
Progression Free Survival
Time Frame: 2 years from NIB101 infusion
|
Time from NIB101 infusion to the date of disease progression or death from any cause.
|
2 years from NIB101 infusion
|
|
Overall Survival
Time Frame: 2 years from NIB101 infusion
|
Time from NIB101 infusion to time of death due to any cause
|
2 years from NIB101 infusion
|
|
Pharmacokinetics (Cmax)
Time Frame: 2 years from NIB101 infusion
|
Maximum peak of NIB101
|
2 years from NIB101 infusion
|
|
Pharmacokinetics (Tmax)
Time Frame: 2 years from NIB101 infusion
|
Time to maximum peak of NIB101
|
2 years from NIB101 infusion
|
|
Pharmacokinetics (T1/2)
Time Frame: 2 years from NIB101 infusion
|
Half life of NIB101
|
2 years from NIB101 infusion
|
|
Pharmacokinetics (Clast)
Time Frame: 2 years from NIB101 infusion
|
Concentration of last quantified NIB101
|
2 years from NIB101 infusion
|
|
Pharmacokinetics (Tlast)
Time Frame: 2 years from NIB101 infusion
|
Time of Clast observed
|
2 years from NIB101 infusion
|
|
Pharmacokinetics (AUC)
Time Frame: 2 years from NIB101 infusion
|
Area under the curve of NIB101
|
2 years from NIB101 infusion
|
|
Immunogenicity
Time Frame: 2 years from NIB101 infusion
|
Evaluation of an anti-CAR antibody response
|
2 years from NIB101 infusion
|
|
Replication Competent Retrovirus (RCR)
Time Frame: 2 years from NIB101 infusion
|
Number of cases of positive RCR
|
2 years from NIB101 infusion
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Noile-Immune Biotech, Inc., Noile-Immune Biotech, Inc
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- NIB101-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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