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Solid TumorPhase 1NCT05192174

Study of NIB101 in Participants With Advanced Solid Tumors

A Phase 1 study testing NIB101 in people with Solid Tumor, run by Noile-Immune Biotech, Inc at 2 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
NIB101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesJapan
Study dates
24 Jan 2022to 16 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • National Cancer Center Hospital

    Chuo Ku, Tokyo

  • National Cancer Center Hospital East

    Kashiwa, Chiba

Other trials in Japan

About this study

Official title: An Open-Label Non-Randomized Phase 1 Dose Escalation and Dose Expansion Study of NIB101 in Participants With Advanced Solid Tumors

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.

Read the detailed description

The screening begins by signing the informed consent form and determining the participant's initial eligibility. Alternatively, in advance, the prescreening enables participants to confirm GM2 expression using the archived samples by signing the prescreening ICF prior to the screening. After the consent is obtained and the eligibility of participants is confirmed, the participant will undergo apheresis. Lymphodepleting chemotherapy will be administered prior to NIB101 infusion. After manufacturing of NIB101, participants will receive a single dose of NIB101 intravenously on Day 0 and be followed for safety and efficacy.

Conditions
Solid Tumor
Being tested
NIB101

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIB101Biological

    NIB101

Study groups in NCT05192174
Study groupRoleWhat they receive
NIB101 Dose Level 1Experimental1 x 10^7 cells/body as chimeric antigen receptor (CAR) positive viable cells will be administered intravenously on Day 0.
Receives: Biological: NIB101
NIB101 Dose Level 2Experimental1 x 10^8 cells/body as CAR positive viable cells will be administered intravenously on Day 0.
Receives: Biological: NIB101
NIB101 Expansion CohortExperimentalRecommended dose determined on dose escalation phase will be administered intravenously on Day 0.
Receives: Biological: NIB101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities

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

    Measured: 28 days after NIB101 infusion

  2. Adverse Events

    Number of participants with adverse events

    Measured: 2 years from NIB101 infusion

Secondary outcomes (15)

  1. Objective Response

    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

    Measured: 2 years from NIB101 infusion

  2. Overall Response Rate

    Percentage of subjects who achieved PR or better

    Measured: 2 years from NIB101 infusion

  3. Disease Control Rate

    Percentage of subjects who achieved SD or better

    Measured: 2 years from NIB101 infusion

  4. Duration of Response

    Time from first documentation of response (PR or better) to first documentation of disease progression or death from any cause

    Measured: 2 years from NIB101 infusion

  5. Time To Response

    Time from NIB101 infusion to the initial documented response (PR or better)

    Measured: 2 years from NIB101 infusion

  6. Progression Free Survival

    Time from NIB101 infusion to the date of disease progression or death from any cause.

    Measured: 2 years from NIB101 infusion

  7. Overall Survival

    Time from NIB101 infusion to time of death due to any cause

    Measured: 2 years from NIB101 infusion

  8. Pharmacokinetics (Cmax)

    Maximum peak of NIB101

    Measured: 2 years from NIB101 infusion

  9. Pharmacokinetics (Tmax)

    Time to maximum peak of NIB101

    Measured: 2 years from NIB101 infusion

  10. Pharmacokinetics (T1/2)

    Half life of NIB101

    Measured: 2 years from NIB101 infusion

  11. Pharmacokinetics (Clast)

    Concentration of last quantified NIB101

    Measured: 2 years from NIB101 infusion

  12. Pharmacokinetics (Tlast)

    Time of Clast observed

    Measured: 2 years from NIB101 infusion

  13. Pharmacokinetics (AUC)

    Area under the curve of NIB101

    Measured: 2 years from NIB101 infusion

  14. Immunogenicity

    Evaluation of an anti-CAR antibody response

    Measured: 2 years from NIB101 infusion

  15. Replication Competent Retrovirus (RCR)

    Number of cases of positive RCR

    Measured: 2 years from NIB101 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start24 Jan 2022
  3. Primary completion16 May 2025
  4. Study completion16 May 2025

Why it stopped: due to the reconsideration of development strategy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05192174
Sponsor's protocol ID
NIB101-01
Status last verified
May 2025
First submitted
24 Dec 2021
Last updated
23 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NIB101 in people with Solid Tumor, run by Noile-Immune Biotech, Inc at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: due to the reconsideration of development strategy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (time frame: 28 days after NIB101 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05192174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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