Study of NIB101 in Participants With Advanced Solid Tumors

NCT05192174 | Terminated Phase 1

• 1 other identifier: NIB101-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities

  Specific adverse events defined in the protocol and related to NIB101 infusion

  28 days after NIB101 infusion

• Adverse Events

  Number of participants with adverse events

  2 years from NIB101 infusion

Secondary Outcomes (15)

• Objective Response

  2 years from NIB101 infusion

• Overall Response Rate

  2 years from NIB101 infusion

• Disease Control Rate

  2 years from NIB101 infusion

• Duration of Response

  2 years from NIB101 infusion

• Time To Response

  2 years from NIB101 infusion

Study Arms (3)

NIB101 Dose Level 1

EXPERIMENTAL

1 x 10\^7 cells/body as chimeric antigen receptor (CAR) positive viable cells will be administered intravenously on Day 0.

Biological: NIB101

NIB101 Dose Level 2

EXPERIMENTAL

1 x 10\^8 cells/body as CAR positive viable cells will be administered intravenously on Day 0.

Biological: NIB101

NIB101 Expansion Cohort

EXPERIMENTAL

Recommended dose determined on dose escalation phase will be administered intravenously on Day 0.

Biological: NIB101

Interventions

NIB101 BIOLOGICAL

NIB101

NIB101 Dose Level 1; NIB101 Dose Level 2; NIB101 Expansion Cohort

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noile-Immune Biotech, Inc: lead

Study Sites (2)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Location

Study Officials

• Noile-Immune Biotech, Inc.

  Noile-Immune Biotech, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 14, 2022
• Study Start: January 24, 2022
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)