MRD-Guided BCMA/CD3 Bispecific Antibody Treatment After S... | NCT07409454

Studies
MRD-Guided BCMA/CD3 Bispecific Antibody Treatment After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma

NCT07409454

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Not yet recruiting

Last Update Posted

Feb 13, 2026Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Multiple Myeloma

Interventions

anti-BCMA/CD3 bispecific antibody

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Dec 9, 2025

First Submission Date that Met QC Criteria

Feb 6, 2026

First Posted Date

Feb 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2026

Last Update Posted Date

Feb 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of the BCMA/CD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
BsAbs-treatment group	Experimental		Drug: anti-BCMA/CD3 bispecific antibody

Name	Type	Description	Arm Group Labels	Other Names
anti-BCMA/CD3 bispecific antibody	Drug	Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).	BsAbs-treatment group

Measure	Description	Time Frame
Minimal residual disease (MRD) negativity conversion rate		Up to 24 months

Measure	Description	Time Frame
Duration of MRD negativity		Up to 24 months
Progression-Free Survival		From enrollment to the date of disease progression or death, up to approximately 24 months.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be able to understand and voluntarily signs the informed consent form (ICF).
Age ≥ 18 years.
Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
MRD positivity (≥10-⁵) detected by EuroFlow.
Previous therapy limited to first-line treatment only, including: (1) Induction therapy with a 3- or 4-drug regimen containing a proteasome inhibitor and/or an immunomodulatory drug and/or an anti-CD38 monoclonal antibody; (2) Single or tandem autologous stem cell transplantation (ASCT); (3) Up to 2-4 cycles of consolidation therapy post-ASCT are permitted, with the total number of induction plus consolidation cycles not exceeding 8.
Completion of ASCT within ≤12 months from the start of induction therapy; and ≤6 months from the most recent ASCT at enrollment (≤7 months if consolidation therapy was administered).
No prior maintenance therapy.
Achieved at least a partial response (≥PR) according to the IMWG 2016 response criteria.
Presence of measurable disease at diagnosis.

Exclusion Criteria:

Prior treatment with genetically modified adoptive cellular therapy.
History of allogeneic stem cell transplantation or solid organ transplantation.
Disease progression prior to enrollment (per IMWG 2016 response criteria), or presence of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or light-chain amyloidosis not attributable to symptomatic multiple myeloma.
Central nervous system involvement.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders