TNB-383B for Multiple Myeloma
Recruiting at 32 trial locations
BB
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Teneobio, Inc.
Must be taking: Proteasome inhibitors, Immunomodulatory imides, Anti-CD38 antibodies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This trial is testing TNB-383B, a special antibody, in patients with hard-to-treat multiple myeloma. The treatment helps immune cells find and destroy cancer cells. It aims to offer a new option for patients who have not responded to multiple previous treatments.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have received any cancer treatment or major surgery within 21 days before starting the trial.
What data supports the effectiveness of the drug TNB-383B for treating multiple myeloma?
Research Team
TI
TeneoOne Inc
Principal Investigator
TeneoOne Inc.
Eligibility Criteria
This trial is for people with Multiple Myeloma who've tried at least three previous treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. They need to have certain levels of M-protein or free light chains in their blood and good kidney function. People can't join if they've had other cancers (with some exceptions), major heart issues, severe nerve damage, recent cancer treatment or surgery, or active infections.Inclusion Criteria
You have a high level of M-protein in your blood.
Your blood test shows high levels of a specific protein called free light chain and an abnormal ratio of this protein in your blood.
Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival bone marrow tumor tissue that was collected within 6 months prior to screening and without intervening treatment.
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Exclusion Criteria
Has any medical or psychiatric condition which in the opinion of the investigator or study Medical Monitor places the participant 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 participant safety or study results.
I have a history of specific blood, nerve, organ, hormone, protein, or skin conditions.
I have severe nerve damage in my hands or feet.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive escalating doses of TNB-383B to determine the maximum tolerated dose or recommended phase 2 dose
Up to 21 days per cohort
Multiple visits (in-person) for dose administration and monitoring
Dose Expansion
Participants receive the recommended phase 2 dose to further evaluate safety and pharmacokinetics
Up to 48 months
Regular visits (in-person) every 3-4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 48 months
Treatment Details
Interventions
- TNB-383B
Trial OverviewTNB-383B is being tested on patients with relapsed/refractory Multiple Myeloma. The study has four parts: testing different doses every three weeks (Arm A), expanding the dose group once the best dose is found (Arm B), and then further testing this dose every four weeks (Arm E) and every three weeks (Arm F).
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Arm F: Monotherapy Dose CExperimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose C.
Group II: Arm E: Monotherapy Once Every 4 Weeks (Q4W)Experimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose A.
Group III: Arm B: Dose Expansion Dose BExperimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose B.
Group IV: Arm B: Dose Expansion Dose AExperimental Treatment1 Intervention
An expansion cohort will be enrolled at the recommended phase 2 Dose A.
Group V: Arm A: Dose EscalationExperimental Treatment1 Intervention
Up to 15 cohorts of participants receiving sequentially ascending doses of TNB-383B are planned until maximum tolerated dose is reached or recommended phase 2 dose is identified.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teneobio, Inc.
Lead Sponsor
Trials
4
Recruited
490+
TeneoOne Inc.
Lead Sponsor
Trials
5
Recruited
860+
AbbVie
Industry Sponsor
Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Findings from Research
TNB-383B effectively induces the killing of plasma cells in bone marrow from patients with relapsed multiple myeloma, showing dose-dependent lysis starting at very low doses (0.001 μg).
The treatment leads to significant degranulation of cytotoxic T lymphocytes (CTLs) and modulates cytokine responses, with notable increases in IL-2/TNFα and IP10, indicating a robust immune response without significant T cell expansion or severe cytokine release syndrome.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Ex vivo efficacy of BCMA-bispecific antibody TNB-383B in relapsed/refractory multiple myeloma.Foureau, DM., Bhutani, M., Robinson, M., et al.[2023]
ABBV-383, a bispecific antibody targeting B-cell maturation antigen and CD3, showed a promising overall response rate (ORR) of 68% in patients with relapsed/refractory multiple myeloma (RRMM) at doses of 40 mg or higher, indicating its potential efficacy as a treatment option.
The treatment was generally well tolerated, with common side effects including neutropenia (37%) and cytokine release syndrome (57%), and no deaths were deemed related to the study drug, suggesting a favorable safety profile for further clinical evaluation.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma.D'Souza, A., Shah, N., Rodriguez, C., et al.[2023]
The treatment landscape for multiple myeloma (MM) has significantly improved, with four new drugs approved in 2015 alone, leading to better patient outcomes than seen in any other cancer over the past decade.
Several new investigational agents, such as Isatuximab and marizomib, show promising efficacy in clinical trials, indicating a strong potential for future regulatory approval and further advancements in MM treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
New investigational drugs with single-agent activity in multiple myeloma.Rajan, AM., Kumar, S.[2022]
References
Ex vivo efficacy of BCMA-bispecific antibody TNB-383B in relapsed/refractory multiple myeloma. [2023]
A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma. [2023]
New investigational drugs with single-agent activity in multiple myeloma. [2022]
Emerging therapies for relapsed/refractory multiple myeloma: CAR-T and beyond. [2023]
An anti-leishmanial thiadiazine agent induces multiple myeloma cell apoptosis by suppressing the nuclear factor kappaB signalling pathway. [2022]
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