TNB-383B for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Teneobio, Inc.

No Placebo Group

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.

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.

+8 more

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.

+9 more

Participant Groups

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).

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.