Evaluating QLS32015 for patients with recurrent multiple myeloma
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS32015 Injection in Patients With Relapsed or Refractory Multiple Myeloma
This study is testing a new drug called QLS32015 to see if it can safely help people with recurrent multiple myeloma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05920876 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of QLS32015, a bispecific antibody targeting GPRC5D and CD3, in patients with relapsed or refractory multiple myeloma. It includes three phases: screening, treatment, and post-treatment follow-up, with a total duration of up to two years. The primary focus is to determine the recommended Phase 2 dose and evaluate the drug's pharmacokinetics and preliminary antitumor activity in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented relapsed or refractory multiple myeloma and measurable disease.
Not a fit: Patients with active plasma cell leukemia, systemic light chain amyloidosis, or severe mental or medical illnesses 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: While this approach is novel, similar studies targeting bispecific antibodies in multiple myeloma have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years old, regardless of gender. * Subjects should be willing and able to comply with the study schedule and protocols. * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria. * Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal. Exclusion Criteria: * Known hypersensitivity to any of the ingredients of this product. * Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis. * Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
Where this trial is running
Tianjin, Tianjin
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Lugui Qiu — Chinese Academy of Medical Sciences & Peking Union Medical College
- Study coordinator: Gang An
- Email: angang@ihcams.ac.cn
- Phone: 008613502181109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.