Multiple MyelomaNCT04453397
Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma
A study testing TNB-383B in people with Multiple Myeloma, run by TeneoOne Inc. at 1 site in United States.
Trial summary
This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit in MM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- TNB-383B
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Adequate bone marrow function
- eGFR ≥ 30 mL/min
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Serum calcium (corrected for albumin) at or below the ULN range
Who cannot join
- Candidate for treatment regimens known to provide clinical benefit in MM
- Active infection requiring parenteral anti-infective treatment
- Any medical or psychiatric condition which in the opinion of the investigator or Teneobio Medical Monitor places the subject at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of subject safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma
This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit in MM.
- Conditions
- Multiple Myeloma
- Being tested
- TNB-383B
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNB-383BDrug
TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- TeneoOne Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Buelow, Study chair, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453397
- Sponsor's protocol ID
- TNB383B.9001
- Status last verified
- Sep 2021
- First submitted
- 26 Jun 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04453397
- Acronym / sponsor ID
- TNB383B.9001
- Conditions
- Multiple Myeloma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- TeneoOne Inc.Industry (pharma, biotech, devices)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit in MM.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adequate bone marrow function
- eGFR ≥ 30 mL/min
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Serum calcium (corrected for albumin) at or below the ULN range
Key exclusion criteria (3 listed)
- Candidate for treatment regimens known to provide clinical benefit in MM
- Active infection requiring parenteral anti-infective treatment
- Any medical or psychiatric condition which in the opinion of the investigator or Teneobio Medical Monitor places the subject at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of subject safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNB-383BTNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Buelow study chair
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNB-383B in people with Multiple Myeloma, run by TeneoOne Inc. at 1 site in United States.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
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.
Where can I read the original study information?
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 Sep 2021.