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Evaluating BCD-248 for treating relapsed or refractory multiple myeloma

An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects With Relapsed/Refractory Multiple Myeloma

Phase 2 Interventional Biocad · NCT06668792

This study is testing a new treatment called BCD-248 to see if it can help people with relapsed or refractory multiple myeloma who have already tried other therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorBiocad Industry-sponsored
Locations20 sites (Kaliningrad and 19 other locations)
Trial IDNCT06668792 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of BCD-248 in patients suffering from relapsed or refractory multiple myeloma. Participants must have previously undergone at least two lines of therapy and show measurable disease at screening. The study will involve administering BCD-248 and monitoring the patients for responses and any adverse effects. The trial is open-label, meaning both the researchers and participants will know the treatment being administered.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of multiple myeloma who have received at least two prior lines of therapy.

Not a fit: Patients who have previously been treated with anti-BCMA or anti-CD3 drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have explored therapies for multiple myeloma, but the specific approach with BCD-248 is novel and has not been widely tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed informed consent form.
2. Age ≥18 years.
3. Documented diagnosis of multiple myeloma according to the IMWG criteria.
4. Measurable disease at screening.
5. Subjects who received at least 2 lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.
6. Documented progression according to the IMWG criteria during or after the last line of therapy.
7. Evidence of at least a partial response according to the IMWG criteria to at least 1 previous line of therapy.
8. ECOG score 0-2.

Exclusion Criteria:

1. Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.
2. Use of any investigational medicinal products or medical devices within 30 days or 5 half-lives (whichever is longer) prior to the expected start of the study therapy or planned use of investigational medicinal products or medical devices during participation in this study, except for the use described in this Protocol.
3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the expected start of the study therapy or a history of allogenic stem cell transplantation, regardless of when it was performed.
4. Planned hematopoietic stem cell transplantation before disease progression during this study.
5. A history of other malignancies within 5 years before screening, excluding squamous and basal cell skin cancers, carcinoma in situ of the cervix or breast, or other malignancies, which, in the opinion of the Investigator, have been adequately treated and have a minimal risk of recurrence within 5 years.
6. Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:

   * Stable angina pectoris, functional class III-IV.
   * Unstable angina and/or myocardial infarction within less than 6 months before the expected start of the study therapy.
   * Chronic heart failure, NYHA class III-IV;
   * Clinically significant (in the Investigator's opinion) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the expected start of the study therapy);
   * Moderate to severe asthma, grade III-IV chronic obstructive pulmonary disease, a history of angioedema, severe respiratory failure;
   * Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, or psoriasis) that do not require systemic therapy are eligible);
   * Any infection within 14 days prior to the expected start of the study therapy, requiring systemic etiotropic therapy or which, in the opinion of the Investigator, may increase the risk of infectious complications;
   * Any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.
7. Subjects with amyloidosis.
8. Clinical signs of meningeal involvement of multiple myeloma.
9. HIV infection, active HBV infection, hepatitis C.
10. Major surgery within less than 14 days prior to the expected start of the study therapy, incomplete recovery from surgery, or planned surgery during participation in the study.
11. Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period and within 180 days after receiving the last dose of the IP.

Where this trial is running

Kaliningrad and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Multiple Myeloma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.