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JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Study title shortened, about 5 wordsv3 Show 1 more changeShow less
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2026 to Jun 25, 2026v2 Show 1 more changeShow less
    • Start date changed from estimate of May 2026 to Jun 25, 2026
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase I, multicenter, single-arm, open-label clinical study designed to evaluate the safety and tolerability of JL19001 Injection as monotherapy (Phase Ia) or in combination with standard therapy (Phase Ib) in patients with AST and r/r B-NHL. Only the Phase Ia protocol design is registered at this time. A total of 6 dose cohorts are planned for Phase Ia, i.e., 1, 5, 10, 15, 20, and 25 μg/kg, with the administration route being subcutaneous injection. A traditional 3 + 3 dose escalation design will be used. The MTD and Recommended Maximum Add-on Dose (RMAD) for JL19001 Injection will be determined.
Trial Details
NCT Number NCT07603479
Lead Sponsor Jecho Biopharmaceuticals Co., Ltd.
Conditions Malignancies, Solid Malignant Tumor, NHL (Non-Hodgkin Lymphoma), Solid Tumor Cancer
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov