Relapsed Refractory Multiple Myeloma (RRMM)Phase 1CM336-001NCT07407010
BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM
A Phase 1 study testing CM336 (BCMA/CD3 bispecific antibody) in people with Relapsed Refractory Multiple Myeloma (RRMM), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Refractory Multiple Myeloma (RRMM)
- What is being tested?
- CM336 (BCMA/CD3 bispecific antibody)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 May 2028
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).2.Age ≥18 years.3.Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).4.Relapsed/Refractory MM (RRMM) meeting one of the following:Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.Secondary plasma cell leukemia (sPCL):MM diagnosis per Chinese Guidelines (2022), plusPeripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells >2×10⁹/L.5.Successful apheresis for CAR-T cell manufacturing.6.ECOG performance status ≤3.7.No active infections:HBV-DNA negative, HCV-RNA negative, HIV negative.8.Liver function:Total bilirubin <1.5×ULN (<3×ULN for Gilbert's syndrome).AST/ALT <3×ULN.9.Renal function: Calculated CrCl ≥30 mL/min (Cockcroft-Gault formula).10.Baseline oxygen saturation >92% (room air).11.Hematologic criteria (within 7 days of screening):WBC ≥1.0×10⁹/L, ANC ≥1.0×10⁹/L, hemoglobin ≥70 g/L, andPlatelets ≥75×10⁹/L (or ≥50×10⁹/L if bone marrow plasma cells ≥50%).Investigator discretion permitted for clinical justification.12.Growth factor restrictions:2-week washout required for erythropoietin, G-CSF, GM-CSF, or thrombopoietin agonists (e.g., eltrombopag).13.Reproductive requirements:Non-childbearing women eligible;Childbearing potential women: Negative serum/urine pregnancy test (β-hCG) at screening.14.Contraception:Males/females of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.16.Compliance: Willing and able to complete study procedures and follow-up.
Who cannot join
- 1.Prior GPRC5D-targeted immunotherapy.2.Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).3.Grade >2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).4.Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.5.Initiation of bridging therapy for BCMA CAR-T cell treatment.6.Unstable/active cardiovascular or cerebrovascular disease, including any of:a. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.b. Uncontrolled hypertension (>140/90 mmHg with historical readings >180/100 mmHg within 6 months).c. Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB/RBBB).d. LVEF <40% by echocardiography.e. Stroke or intracranial hemorrhage within 12 months before screening.f. Pre-treatment severe thrombotic events.7.Active HIV infection or seropositivity.8.Active HBV/HCV infection:HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).HCV: HCV Ab(+) requires negative HCV-RNA PCR.9.Pregnancy or lactation.10.Active gastrointestinal disorders affecting swallowing or drug absorption.11.Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty/vertebroplasty; allowed: local anesthesia procedures).12.Live vaccines within 4 weeks before first study dose.13.Active psychiatric/medical conditions impairing compliance/consent capacity per investigator judgment.14.Contraindications to required concomitant medications/supportive care.15.Any condition interfering with study procedures.16.Inability/unwillingness to comply with protocol.
About this study
Official title: A Prospective Single-Arm, Single-Center Study of BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in Relapsed or Refractory Multiple Myeloma
This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).
- Being tested
- CM336 (BCMA/CD3 bispecific antibody)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM336 (BCMA/CD3 bispecific antibody)Biological
CM336 is a BCMA × CD3 bispecific antibody.
| Study group | Role | What they receive |
|---|---|---|
| CM336 | Experimental | Not described Receives: Biological: CM336 (BCMA/CD3 bispecific antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with CM336 injection
Measured: Minimum 2 years after infusion
Safety and Tolerability
The incidence of treatment-emergent adverse events (TEAES)
Measured: Minimum 2 years after infusion
Secondary outcomes (4)
Time to Response (TTR)
Time from first BCMA × CD3 bispecific antibody infusion to first hematologic response， Depth of best hematologic response: The highest-level response achieved at any timepoint.
Measured: Minimum 2 years after infusion.
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from first documented hematologic response (≥ partial response [PR]) to disease progression or death due to progression, whichever occurred first
Measured: Minimum 2 years after infusion
Overall Survival (OS)
Measured: Minimum 2 years after infusion
Progression-Free Survival (PFS)
Measured: Minimum 2 years after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 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 Myeloma (RRMM)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407010
- Sponsor's protocol ID
- IIT2024047
- Acronym
- CM336-001
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm, Single-Center Study of BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07407010
- Acronym / sponsor ID
- CM336-001 / IIT2024047
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 12 Feb 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 study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM336 | Experimental | Biological: CM336 (BCMA/CD3 bispecific antibody) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).2.Age ≥18 years.3.Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).4.Relapsed/Refractory MM (RRMM) meeting one of the following:Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.Secondary plasma cell leukemia (sPCL):MM diagnosis per Chinese Guidelines (2022), plusPeripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells >2×10⁹/L.5.Successful apheresis for CAR-T cell manufacturing.6.ECOG performance status ≤3.7.No active infections:HBV-DNA negative, HCV-RNA negative, HIV negative.8.Liver function:Total bilirubin <1.5×ULN (<3×ULN for Gilbert's syndrome).AST/ALT <3×ULN.9.Renal function: Calculated CrCl ≥30 mL/min (Cockcroft-Gault formula).10.Baseline oxygen saturation >92% (room air).11.Hematologic criteria (within 7 days of screening):WBC ≥1.0×10⁹/L, ANC ≥1.0×10⁹/L, hemoglobin ≥70 g/L, andPlatelets ≥75×10⁹/L (or ≥50×10⁹/L if bone marrow plasma cells ≥50%).Investigator discretion permitted for clinical justification.12.Growth factor restrictions:2-week washout required for erythropoietin, G-CSF, GM-CSF, or thrombopoietin agonists (e.g., eltrombopag).13.Reproductive requirements:Non-childbearing women eligible;Childbearing potential women: Negative serum/urine pregnancy test (β-hCG) at screening.14.Contraception:Males/females of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.16.Compliance: Willing and able to complete study procedures and follow-up.
Key exclusion criteria (1 listed)
- 1.Prior GPRC5D-targeted immunotherapy.2.Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).3.Grade >2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).4.Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.5.Initiation of bridging therapy for BCMA CAR-T cell treatment.6.Unstable/active cardiovascular or cerebrovascular disease, including any of:a. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.b. Uncontrolled hypertension (>140/90 mmHg with historical readings >180/100 mmHg within 6 months).c. Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB/RBBB).d. LVEF <40% by echocardiography.e. Stroke or intracranial hemorrhage within 12 months before screening.f. Pre-treatment severe thrombotic events.7.Active HIV infection or seropositivity.8.Active HBV/HCV infection:HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).HCV: HCV Ab(+) requires negative HCV-RNA PCR.9.Pregnancy or lactation.10.Active gastrointestinal disorders affecting swallowing or drug absorption.11.Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty/vertebroplasty; allowed: local anesthesia procedures).12.Live vaccines within 4 weeks before first study dose.13.Active psychiatric/medical conditions impairing compliance/consent capacity per investigator judgment.14.Contraindications to required concomitant medications/supportive care.15.Any condition interfering with study procedures.16.Inability/unwillingness to comply with protocol.
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 |
|---|---|---|
| CM336 (BCMA/CD3 bispecific antibody)CM336 is a BCMA × CD3 bispecific antibody. | Biological | CM336 |
Primary outcome
Overall Response Rate (ORR)
Time frame: Minimum 2 years after infusion
The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with CM336 injection
Safety and Tolerability
Time frame: Minimum 2 years after infusion
The incidence of treatment-emergent adverse events (TEAES)
4 secondary outcomes
Time to Response (TTR)
Time frame: Minimum 2 years after infusion.
Duration of Response (DOR)
Time frame: Minimum 2 years after infusion
Overall Survival (OS)
Time frame: Minimum 2 years after infusion
Progression-Free Survival (PFS)
Time frame: Minimum 2 years after infusion
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 12 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM336 (BCMA/CD3 bispecific antibody) in people with Relapsed Refractory Multiple Myeloma (RRMM), run by Institute of Hematology & Blood Diseases Hospital, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
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?
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?
Overall Response Rate (ORR) (time frame: Minimum 2 years after infusion). The study lists 2 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 12 Feb 2026.