Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07018050
Phase
PHASE2
Status
Recruiting
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Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QLS32015 — DRUG
    QLS32015 will be administered subcutaneously
  • Pomalidomide — DRUG
    Pomalidomide will be self-administered as a single dose orally
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally or intravenously
  • QL2109 or Daratumumab — DRUG
    QL2109 or Daratumumab will be administered subcutaneously.
  • Bortezomib — DRUG
    Bortezomib will be administered subcutaneously
  • Lenalidomide — DRUG
    Lenalidomide will be self-administered as a single dose orally

Study Details

The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.

Key Dates

Start date
Sep 12, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QLS32015(SC) in combination with Pomalidomide
    Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Experimental: QLS32015(SC) in combination with QL2109 or Daratumumab.
    Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Experimental: QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide
    Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
  • Experimental: QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide
    Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug

Primary Outcome Measure

ORR (Partial Response [PR] or Better) [ Time Frame: Up to 2 years ]

Central Contacts

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