What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bispecific antibodies, proteasome inhibitors, and immunomodulatory drugs, have a range of side effects. Bispecific antibodies like TNB-383B can cause cytokine release syndrome, infections, and cytopenias. Proteasome inhibitors, such as bortezomib and carfilzomib, often lead to peripheral neuropathy, gastrointestinal issues, and hematologic toxicities. Immunomodulatory drugs like lenalidomide and pomalidomide are associated with risks of blood clots, cytopenias, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including monoclonal antibodies and proteasome inhibitors. Daratumumab, a CD38-targeting monoclonal antibody, has shown significant efficacy in relapsed or refractory Multiple Myeloma and is often used in combination with other agents like bortezomib and dexamethasone. Bortezomib, a proteasome inhibitor, is another cornerstone in Multiple Myeloma treatment, often combined with cyclophosphamide and dexamethasone (VCd). While specific approvals for BCMA x CD3 T-cell engaging bispecific antibodies like TNB-383B are not detailed, the development of such therapies represents a promising advancement in targeting specific antigens in Multiple Myeloma.

What other types of research exist?

Promising novel alternatives to TNB-383B for Multiple Myeloma patients include: 1) CAR T-cell therapies targeting BCMA, such as idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti), which have shown significant efficacy in relapsed or refractory Multiple Myeloma. 2) Bispecific antibodies like teclistamab, which also target BCMA and have demonstrated encouraging results in clinical trials. 3) Antibody-drug conjugates (ADCs) such as belantamab mafodotin, which target BCMA and deliver cytotoxic agents directly to myeloma cells.

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CAR T-cell Therapy

TNB-383B for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Research Sponsored by Teneobio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has confirmed evidence of relapse/progression from the immediately prior MM therapy, or participant is relapsed/refractory to the immediately prior MM therapy.

Must have an estimated glomerular filtration rate >= 30 mL/min as estimated by the Modification of Diet in Renal Disease formula.

Must not have

History of plasma cell leukemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome, or amyloidosis.

History of Grade >= 3 peripheral neuropathy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

TNB-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).

What are the potential side effects?

As TNB-383B is still in early testing phases, specific side effects are not fully known but may include typical reactions related to immune system activation such as fever, fatigue, infusion-related reactions and potential impact on normal blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma has worsened or not responded to my last treatment.

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My kidney function is good enough, based on a specific test.

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I've had 3+ treatments including PI, IMiD, and anti-CD38.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of specific blood, nerve, organ, hormone, protein, or skin conditions.

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I have severe nerve damage in my hands or feet.

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I am currently being treated for a serious infection.

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I have received BCMA-targeted therapy before.

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I haven't had cancer treatment or major surgery in the last 21 days or within 5 half-lives of a cancer drug.

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My myeloma has affected my brain or spinal cord.

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I had a stem cell transplant recently.

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I have a history of serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUClast)

Clearance (CL) of TNB-383B

Maximum Observed Plasma Concentration of TNB-383B (Cmax)

+6 more

Secondary study objectives

Duration of Objective Response (DOR)

Objective Response Rate (ORR)

Percentage of Participants with Overall Survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), and monoclonal antibodies (e.g., daratumumab). These treatments work by targeting different aspects of myeloma cell survival and proliferation. Proteasome inhibitors disrupt protein degradation, leading to cell death. Immunomodulatory drugs enhance the immune system's ability to fight cancer cells. Monoclonal antibodies target specific proteins on myeloma cells, marking them for destruction by the immune system. Treatments like TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, specifically target the B-cell maturation antigen (BCMA) on myeloma cells and engage T-cells to kill these cancer cells. This targeted approach is crucial for Multiple Myeloma patients as it offers a more precise attack on cancer cells, potentially leading to better outcomes and fewer side effects compared to broader treatments.