Trial Purpose

The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination with nemtabrutinib in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter’s transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with nemtabrutinib with respect to objective response rate.

MCL: relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton’s tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy
RT: relapsed or refractory disease after at least 1 prior systemic therapy
MCL: relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi
FL and CLL: relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy

The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR).

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT05458297

When speaking to your doctor, please have the trial identifier number available.

About The Trial

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Phase 2

Tests the medicine or vaccine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy.

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Dates

  • Actual study start date July 21, 2022
  • Estimated primary completion date March 13, 2027
  • Estimated study completion date April 26, 2027

Eligibility

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Conditions

Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Richter Transformation Lymphoma

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

What Can You Do Next?

If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.

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Discuss With Your Doctor

Print this page or email it to your doctor to discuss at your next visit.

CLINICALTRIALS.GOV IDENTIFIER:

NCT05458297

When speaking to your doctor, please have the trial identifier number available.

Participating in a clinical trial is an important decision.

Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.