Relapsed or Refractory Multiple MyelomaPhase 1/2NCT04735575
A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
A Phase 1/2 study testing EMB-06 in people with Relapsed or Refractory Multiple Myeloma, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- EMB-06
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 20 May 2021to 20 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- Treated with monoclonal antibody for multiple myeloma within 28 days
- Treated with proteasome inhibitors within 14 days
- Treated with immunomodulatory agents within 14 days
- Treated with cytotoxic therapy within 14 days
- Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
- 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
- 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 locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
China7 sites
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Peking University, Third Hospital
Beijing
Guangdong Provincial People's Hospital
Guangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Henan Cancer Hospital
Zhengzhou
Australia3 sites
Sunshine Coast Haematology and Oncology Clinic (SCHOC)
Buderim, Queensland, 4556
One Clinical Research (OCR)
Nedlands, Western Australia, 6009
Epworth Healthcare
Richmond, Victoria, 3121
About this study
Official title: A First-in-human, Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of EMB-06 in Patients With Relapsed or Refractory Multiple Myeloma
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.
Read the detailed description
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.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- EMB-06
- Keywords
- Phase I/II, Bispecific antibody, BCMA, CD3, EMB-06, Immuno-oncology, Dose escalation, Cohort expansion, Relapsed or Refractory Multiple Myeloma, Hematological malignancy
- Medical subject headings
- Recurrence, Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-06Biological
EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3.
| Study group | Role | What they receive |
|---|---|---|
| EMB-06 | Experimental | 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. Receives: Biological: EMB-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Incidence and severity of AE.
Measured: Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Incidence of SAE
Measured: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions.
Incidence of dose interruptions of EMB-06 during treatment as a measure of tolerability.
Measured: Screening up to follow-up (30 days after the last dose)
Dose intensity
Actual amount of drug taken by patients divided by the planned amount.
Measured: Screening up to follow-up (30 days after the last dose)
The incidence of DLTs during treatment.
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Measured: First infusion to the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate (ORR)
Measured by IMWG criteria, only applicable in Phase II part
Measured: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Secondary outcomes (10)
Area under the serum concentration-time curve (AUC) of EMB-06.
Blood samples for serum PK analysis will be obtained (AUC).
Measured: Through treatment until EOT visit, expected average 6 months
Maximum serum concentration (Cmax) of EMB-06.
Blood samples for serum PK analysis will be obtained (Cmax).
Measured: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-06.
Blood samples for serum PK analysis will be obtained (Ctrough).
Measured: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg) of EMB-06.
Blood samples for serum PK analysis will be obtained (Css, avg).
Measured: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-06.
Blood samples for serum PK analysis will be obtained (T1/2).
Measured: Through treatment until EOT visit, expected average 6 months
Systemic clearance (CL) of EMB-06.
Blood samples for serum PK analysis will be obtained (CL).
Measured: Through treatment until EOT visit, expected average 6 months
Steady state volume of distribution (Vss) of EMB-06.
Blood samples for serum PK analysis will be obtained (Vss).
Measured: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-06 as assessed by IMWG criteria.
Preliminary anti-multiple myeloma activity of EMB-06 will be obtained (PFS).
Measured: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Duration of response of EMB-06 as assessed by IMWG criteria
Preliminary anti-multiple myeloma activity of EMB-06 will be obtained (DOR).
Measured: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-06.
Antibodies to EMB-06 will be assessed to evaluate potential immunogenicity.
Measured: Up to End of Treatment Follow Up Period (30 days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start20 May 2021
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Why it stopped: Company's resource optimization and product's development change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation followed by Cohort Expansion Phase at the RP2D.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735575
- Sponsor's protocol ID
- EMB06X101
- Status last verified
- May 2025
- First submitted
- 28 Jan 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of EMB-06 in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04735575
- Acronym / sponsor ID
- EMB06X101
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- Phase I/II, Bispecific antibody, BCMA, CD3, EMB-06, Immuno-oncology, Dose escalation, Cohort expansion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company's resource optimization and product's development change
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation followed by Cohort Expansion Phase at the RP2D.
| Arm | Type | Receives |
|---|---|---|
| EMB-06 | Experimental | Biological: EMB-06In 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMB-06EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3. | Biological | EMB-06 |
Primary outcome
Incidence and severity of adverse events
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence and severity of AE.
Incidence of serious adverse events (SAE)
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of SAE
Incidence of dose interruptions.
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions of EMB-06 during treatment as a measure of tolerability.
Dose intensity
Time frame: Screening up to follow-up (30 days after the last dose)
Actual amount of drug taken by patients divided by the planned amount.
The incidence of DLTs during treatment.
Time frame: First infusion to the end of Cycle 1 (each cycle is 28 days)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Overall Response Rate (ORR)
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Measured by IMWG criteria, only applicable in Phase II part
10 secondary outcomes
Area under the serum concentration-time curve (AUC) of EMB-06.
Time frame: Through treatment until EOT visit, expected average 6 months
Maximum serum concentration (Cmax) of EMB-06.
Time frame: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-06.
Time frame: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg) of EMB-06.
Time frame: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-06.
Time frame: Through treatment until EOT visit, expected average 6 months
Systemic clearance (CL) of EMB-06.
Time frame: Through treatment until EOT visit, expected average 6 months
Steady state volume of distribution (Vss) of EMB-06.
Time frame: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-06 as assessed by IMWG criteria.
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Duration of response of EMB-06 as assessed by IMWG criteria
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-06.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)
Results and safety
The study was stopped early (reason given: Company's resource optimization and product's development change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EMB-06 in people with Relapsed or Refractory Multiple Myeloma, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company's resource optimization and product's development change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: Screening up to follow-up (30 days after the last dose)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.