BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma

NCT06745687 | Not Yet Recruiting

• 1 other identifier: IIT2024009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA/CD3 BiTE, in the treatment of high risk smoldering multiple myeloma.

Conditions

High Risk Smoldering Multiple Myeloma

Keywords

high risk smoldering multiple myeloma; BCMA/CD3 BiTE; CM-336

Outcome Measures

Primary Outcomes (2)

• minimal residual disease netativity(MRD negativity)

  The proportion of abnormal plasma cells occupying nuclear cells in the samples

  baseline, 28 days per cycle, cycle 6 day 28, cycle 12 day 28, cycle 18 day 28, cycle 24 day 28, 1 year and 2 year after end of treatment.

• Adverse events and serious adverse events

  Adverse events (AEs), serious adverse events (SAEs), and assessments of clinical laboratory values

  up to 2 years

Secondary Outcomes (5)

• time to response

  up to 2 years

• Hematologic response rate

  up to 2 years

• progression free survival(PFS)

  up to 2 years after end of therapy

• overall survival(OS)

  up to 2 years after end of therapy.

• duration of response(DOR)

  up to 2 years after end of therapy

Study Arms (1)

CM-336( BCMA/CD3 bispecific antibody)

EXPERIMENTAL

Patients enrolled in the trial will receive CM336 subcutaneously, which is an BCMA/CD3 bispecific antibody therapy.

Drug: CM336

Interventions

CM336 DRUG

Patients received subcutaneous CM-336 80 mg once weekly in 28-d cycles after two step-up priming doses of 3 mg and 20 mg given on day 1 and day 4 of cycle 1 and cycle2. Then patients will be given 160mg every 2 weeks from cycle 3 to cycle 6. The dosing interval is adjusted according to the evaluation of efficacy every 6 cycles from cycle 7 to cycle 24.

CM-336( BCMA/CD3 bispecific antibody)

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Know and voluntarily sign an informed consent form (ICF).
• Age ≥18 years.
• Definite diagnosis of SMM: According to IMWG Criteria 10, the patient must have histologically or cytologically confirmed smoldering multiple myeloma (SMM), including:
• Serum M protein ≥3 g /dL and/or BMPCs≥10%(but not more than 60%)
• No anemia: hemoglobin ≥10 g /dL
• No renal failure: serum creatinine ≥2.0 mg/dL
• No hypercalcemia: calcium ≥10.5 mg/dL
• dissolving bone lesions without radiographic indications: X-ray, CT, or positron emission tomography (PET)/CT without dissolving bone lesions, with no more than 1 lesion on whole-body MRI (Note: In the investigator's judgment, whole-body CT or PET/CT may replace MRI for patients with contraindications or for whom MRI is not available).
• FLC ratio \<100 (unless light chain ≤10 mg /dL is involved) Note: Anemia, renal failure and hypercalcemia are allowed if there is evidence that anemia, renal failure, hypercalcemia or bone lesions are not associated with multiple myeloma (MM).
• High-risk SMM are defined as meeting one or more of the three criteria in the following part: (i) Mayo 2018, (ii) IMWG 2020 and (iii) evolving pattern.
• (i)Mayo 2018
• M protein \> 2 g/dL ② The ratio of affected to unaffected FLC was \> 20 ③BMPC \> 20% of the 3 items meet any 2 or more
• (ii) IMWG 2020
• FLC ratio 0-10: 0 points 10-25: 2 points 25-40: 3 points \>40: 5 points
• ②M protein (g/dL) 0-1.5: indicates 0 points 1.5-3: 3 points \>3: 4 points

You may not qualify if:

• Diagnosis of symptomatic multiple myeloma: refer to the Chinese Guidelines for Diagnosis and Treatment of multiple myeloma (revised in 2022);
• Along with other tumors that must be treated.
• Previously received immunotherapy against BCMA targets.
• The researchers judged that BCMA/CD 3 dual antibody therapy is not suitable, such as severe cardiopulmonary disease and other conditions that are not suitable for BCMA/CD 3 dual antibody therapy.
• Received SMM treatment within six months.
• Known intolerance, allergy or contraindications to BCMA/CD 3 dual anti-active ingredients.
• Patients with unstable or active cardiovascular and cerebrovascular diseases meet any of the following criteria:
• Unstable angina pectoris, symptomatic myocardial ischemia, myocardial infarction, or coronary artery reconstruction had occurred within 180 days prior to initial administration.
• Uncontrolled hypertension (\>140/90 MMHG, with a blood pressure fluctuation of more than 180/100 MMHG over 6 months);
• Uncontrolled and clinically significant conduction abnormalities (e.g., patients with ventricular arrhythmias controlled by antiarrhythmic drug therapy), not excluding patients with first-degree AV block or asymptomatic left anterior bundle branch block/right bundle branch block (LAFB/RBBB);
• Echocardiographic left ventricular ejection fraction (LVEF) \< 40%;
• History of stroke or intracranial hemorrhage within 12 months prior to screening;
• Severe thrombotic events before treatment.
• \) Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
• \) Active hepatitis B or C infection. Screening requires hepatitis serological testing. If hepatitis B surface antigen is positive, a negative DNA polymerase chain reaction (PCR) result is required to be confirmed before enrollment (after anti-HBV treatment, a negative DNA polymerase PCR result is required before enrollment). If the hepatitis C antibody is positive, an RNA PCR test is performed and the result before enrollment is confirmed to be negative.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Keymed Biosciences Co.Ltd: collaborator

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

Location

Central Study Contacts

Gang An, MD, PhD

CONTACT

+86 022-23909171; angang@ihcams.ac.cn

jieqiong zhou, MBBS

CONTACT

008617827063445; zhoujieqiong@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm multi-center trial

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 20, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

CN (1)