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

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

Trial Details

NCT ID
NCT07603479
Phase
PHASE1
Sponsor
Jecho Biopharmaceuticals Co., Ltd.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • JL19001, subcutaneous injection, 1 μg/kg
  • JL19001, subcutaneous injection, 5 μg/kg
  • JL19001, subcutaneous injection,10 μg/kg
  • JL19001, subcutaneous injection,15 μg/kg
  • JL19001, subcutaneous injection,20 μg/kg
  • JL19001, subcutaneous injection,25 μg/kg
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Participants must meet all of the following criteria to be eligible for this study:
  • Age and Gender: Aged ≥ 18 years at the time of signing the Informed Consent Form (ICF), regardless of gender.
  • Disease Status: Patients with histologically or cytologically confirmed advanced solid tumors (AST) or relapsed/refractory B-cell non-Hodgkin lymph…
  • Melanoma: Advanced cutaneous or acral melanoma with progressive disease (PD) after ≥2 prior lines of systemic therapy. Prior treatment must include…

For full eligibility, visit ClinicalTrials.gov.

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