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NCT06049290

A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved 2 years 11 months later, primary endpoint(s) modified.

See at-risk trials from Nanjing Leads Biolabs Co.,Ltd

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Record History

All 13 versions: 13 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Sep 20, 2029
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 4 of 21 sites
  2. Primary endpoint(s) modifiedv12
  3. Eligibility criteria expanded, about 22 words
    • Trial sites reduced: 26 → 21 locations
    • Study description expanded, about 29 words
    • Study title shortened, about 2 words
    v11
  4. Study sites: 20 to 26v10
  5. Eligibility criteria expanded, about 1 word
    • Secondary endpoints: details revised at 4 of 6 entries
    • Study description expanded, about 12 words
    • Site details revised at 3 of 20 sites
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria shortened, about 7 wordsv8 Show 4 more changesShow less
    • Enrollment target: 418 to 342
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 38 words
    • Site details revised at 14 of 20 sites
  2. Study sites: 7 to 20v7
  3. Study sites: 5 to 7v6
  4. Study sites: 7 to 5v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 16, 2023 to Oct 20, 2023
    • Site details revised at 7 of 7 sites
    v4
  6. Study title expanded, about 1 wordv3
  7. Study title revised
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Objective Response Rate (ORR)
Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy).
Dose-limiting toxicities（DLT）
Timeframe: The DLT observation period starts from the first dose until 4 weeks after the full dose first administration (including the step-up dosing period, if any).
Maximum tolerated dose (MTD)
Timeframe: The MTD observation period starts from the first dose until 4 weeks after the full dose first administration (including the step-up dosing period, if any).
Occurrence of adverse event (AE) and serious adverse event (SAE)
Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)

Secondary (6)

Cmax
Tmax
Immunogenicity
Minimal Residual Disease (MRD)
Duration of Response(DOR）
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sBCMA

Arms and interventions

LBL-034Experimental

LBL-034 for Injection; Q2W

Drugs: LBL-034 for Injection

Sites

21 sites in 1 country