Relapsed/Refractory Multiple MyelomaEarly Phase 1NCT07493135
A Study of IMV102 in Patients With Relapsed/Refractory Multiple Myeloma
A Early Phase 1 study testing IMV102 treatment in people with Relapsed/Refractory Multiple Myeloma, run by Suzhou Immunofoco Biotechnology Co., Ltd at 4 sites in China.
Trial summary
This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed/refractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- IMV102 treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 14 Apr 2026to 1 Apr 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Aged 18 to 80 years (inclusive), of either sex.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Diagnosed with relapsed/refractory multiple myeloma according to the IMWG criteria, who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent-based regimen).
- Reproductive Status: Subjects of childbearing potential and their partners must agree to use medically accepted highly effective contraceptive methods (e.g., intrauterine device, condom) from the time of signing the informed consent form until 12 months after the last dose. They must not donate germ cells, including sperm or oocytes, during this period.
- Informed Consent: Subjects must voluntarily sign and date a written informed consent form (ICF) indicating agreement to participate in this study.
- Compliance: Subjects must be willing and able to comply with the scheduled treatment plan, laboratory tests, follow-up, and other study requirements.
Who cannot join
- Pregnancy/Lactation: Women who are pregnant or breastfeeding.
- Other Malignancies: Subjects with a prior or concurrent other malignancy.
- Infectious Diseases: Positive for human immunodeficiency virus (HIV) antibody; active hepatitis B virus infection (HBV-DNA > 10³ IU/mL); acute or chronic active hepatitis C (HCV antibody positive); positive syphilis antibody; cytomegalovirus (CMV) infection (IgM positive or DNA positive).
- Presence of clinically active uncontrolled infection based on assessment done by treating physicians.
- Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment.
- Allergies: History of other severe allergies such as anaphylactic shock; known severe allergic reaction to IMV102 or any of its components; known severe allergic reaction to tocilizumab.
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- Psychiatric Disorders: Subjects with severe mental disorders.
- Transplant History: History of solid organ transplantation.
- Compliance: Subjects whom the investigator assesses as unable or unwilling to comply with the requirements of the study protocol.
- Other Conditions: Subjects with any other concurrent severe and/or uncontrolled medical conditions that, in the judgment of the investigator, make them unsuitable for participation in this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing GoBroad Boren Hospital
Beijing
Yajing Zhang, 010-83605002, 18601333856, 23975701@qq.com
- Not yet recruiting
The second affiliated hospital of Chongqing medical university
Chongqing
Shifeng Lou, 13508331213, 13508331213@163.com
- Not yet recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Juan Du, 15800706091, Juan_du@live.com
- Not yet recruiting
Zhengzhou Yihe Hospital
Zhengzhou
Li Wang, 0371-56570666, 13603846919, zlyywl@qq.com
About this study
Official title: A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed/Refractory Multiple Myeloma
This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed/refractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.
Tumor response will be evaluated according to the International Myeloma Working Group (IMWG) uniform response criteria (2016). Assessments will be performed at baseline, and then at Day 28 post-infusion, Month 2, Month 3, and subsequently every 3 months from Month 3 to Month 24, until the subject completes the 24-month follow-up period, experiences disease progression (PD)/relapse, initiates new anti-tumor therapy, dies, or withdraws from the study, whichever occurs first.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- IMV102 treatment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMV102 treatmentBiological
Eligible patients with relapsed/refractory multiple myeloma will receive an infusion of IMV102 injection, and the safety and efficacy of IMV102 injection will be evaluated within 24 months post-infusion.
| Study group | Role | What they receive |
|---|---|---|
| IMV102 treatment group | Experimental | Not described Receives: Biological: IMV102 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma
Incidence of adverse events and its severity after IMV102 injection treatment
Measured: 24 months post IMV102 infusion
Secondary outcomes (7)
Assessment of pharmacokinetic (about Cmax)
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
Measured: 24 months post IMV102 infusion
Assessment of pharmacokinetic (about Tmax)
The time to reach the maximum concentration (Tmax)
Measured: 24 months post IMV102 infusion
Assessment of pharmacokinetic (about AUC0-28d)
The area under the CAR-T concentration versus time curve (AUC) for 28 days after IMV102 administration
Measured: From first dose of IMV102 to 28 days after IMV102 administration
Assessment of pharmacokinetic (about AUC0-90d)
The area under the CAR-T concentration versus time curve (AUC) for 90 days after IMV102 administration
Measured: From first dose of IMV102 to 90 days after IMV102 administration
Efficacy of IMV102 injection
Overall response rate after IMV102 infusion
Measured: about 2 years
Efficacy of IMV102 injection
Overall survival after IMV102 infusion
Measured: about 2 years
Efficacy of IMV102 injection
Progress-free survival after IMV102 infusion
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start14 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493135
- Sponsor's protocol ID
- IMV102-CT02
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07493135
- Acronym / sponsor ID
- IMV102-CT02
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suzhou Immunofoco Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 25 Mar 2026 (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.
This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed/refractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.
Tumor response will be evaluated according to the International Myeloma Working Group (IMWG) uniform response criteria (2016). Assessments will be performed at baseline, and then at Day 28 post-infusion, Month 2, Month 3, and subsequently every 3 months from Month 3 to Month 24, until the subject completes the 24-month follow-up period, experiences disease progression (PD)/relapse, initiates new anti-tumor therapy, dies, or withdraws from the study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMV102 treatment group | Experimental | Biological: IMV102 treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Aged 18 to 80 years (inclusive), of either sex.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Diagnosed with relapsed/refractory multiple myeloma according to the IMWG criteria, who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent-based regimen).
- Reproductive Status: Subjects of childbearing potential and their partners must agree to use medically accepted highly effective contraceptive methods (e.g., intrauterine device, condom) from the time of signing the informed consent form until 12 months after the last dose. They must not donate germ cells, including sperm or oocytes, during this period.
- Informed Consent: Subjects must voluntarily sign and date a written informed consent form (ICF) indicating agreement to participate in this study.
Key exclusion criteria (10 listed)
- Pregnancy/Lactation: Women who are pregnant or breastfeeding.
- Other Malignancies: Subjects with a prior or concurrent other malignancy.
- Infectious Diseases: Positive for human immunodeficiency virus (HIV) antibody; active hepatitis B virus infection (HBV-DNA > 10³ IU/mL); acute or chronic active hepatitis C (HCV antibody positive); positive syphilis antibody; cytomegalovirus (CMV) infection (IgM positive or DNA positive).
- Presence of clinically active uncontrolled infection based on assessment done by treating physicians.
- Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment.
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 |
|---|---|---|
| IMV102 treatmentEligible patients with relapsed/refractory multiple myeloma will receive an infusion of IMV102 injection, and the safety and efficacy of IMV102 injection will be evaluated within 24 months post-infusion. | Biological | IMV102 treatment group |
Primary outcome
To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma
Time frame: 24 months post IMV102 infusion
Incidence of adverse events and its severity after IMV102 injection treatment
7 secondary outcomes
Assessment of pharmacokinetic (about Cmax)
Time frame: 24 months post IMV102 infusion
Assessment of pharmacokinetic (about Tmax)
Time frame: 24 months post IMV102 infusion
Assessment of pharmacokinetic (about AUC0-28d)
Time frame: From first dose of IMV102 to 28 days after IMV102 administration
Assessment of pharmacokinetic (about AUC0-90d)
Time frame: From first dose of IMV102 to 90 days after IMV102 administration
Efficacy of IMV102 injection
Time frame: about 2 years
Efficacy of IMV102 injection
Time frame: about 2 years
Efficacy of IMV102 injection
Time frame: about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IMV102 treatment in people with Relapsed/Refractory Multiple Myeloma, run by Suzhou Immunofoco Biotechnology Co., Ltd at 4 sites in China.
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 10 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Du, MD (15800706091, Juan_du@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma (time frame: 24 months post IMV102 infusion). 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 3 Sep 2026.