A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma

Study Purpose

The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Able to understand and willing to sign the informed consent form (ICF) - Patients who have been diagnosed with multiple myeloma according to IMWG diagnostic criteria 2014 and have relapsed or refractory multiple myeloma with at least one measurable lesion.

- The patient must have received at least two lines (for patients in the US, at least three lines which should include anti-CD38 antibody) of prior antimyeloma therapies, and must have received treatment with proteasome inhibitors, immunomodulatory agents, and if accessible, an anti-CD38 targeting monoclonal antibody.

- ECOG performance status 0 or 1 for phase I, and ≤2 for phase II.

- Adequate organ function and reasonable laboratory test results to participate in the trial.

- Highly effective contraception.

Exclusion Criteria:

- Life expectancy is less than 3 months.

- Patient participated in any other clinical study within 1 month prior to enrollment in this clinical study.

- Patients with ongoing AE.

- Previously treated with any BCMA-targeted therapy.

(Exception: in Phase 2 portion, up to 10 patients who have received prior anti-BCMA ADC or BCMA targeted CAR-T can be enrolled)

- History of allogeneic stem cell transplantation.

- Previously treated with the following anti-tumor therapy (prior to first dosing of EMB-06) 1.

Treated with monoclonal antibody for multiple myeloma within 28 days. 2. Treated with proteasome inhibitors within 14 days. 3. Treated with immunomodulatory agents within 14 days. 4. Treated with cytotoxic therapy within 14 days. 5. Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable) 6. Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy. 7. Plasmapheresis within 7 days.

- Patient received autologous stem cell transplantation within 12 weeks prior to the start of study treatment.

- Active or historically multiple myeloma related central nervous system involvement.

- Patients requiring high dose of systemic treatment with corticosteroids.

- Patients with active infections, including COVID-19, hepatitis, etc..

- History of severe allergic reactions.

- Patients with severe or uncontrolled cardiovascular disorder requiring treatment.

- Pre-existing other serious medical conditions

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04735575
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai EpimAb Biotherapeutics Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsed or Refractory Multiple Myeloma

Additional Details

This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for EMB-06 in patients with relapsed or refractory multiple myeloma. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Arms & Interventions

Arms

Experimental: EMB-06

In Phase I part: participants enrolled at different time will receive EMB-06 by IV infusion at different ascending dose levels. In Phase II part: participants will receive EMB-06 by IV infusion at previously defined RP2D.

Interventions

Biological: - EMB-06

EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.