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A Phase I Study of JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

NCT07603479 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Malignancies
  • Solid Malignant Tumor
  • NHL (Non-Hodgkin Lymphoma)
  • Solid Tumor Cancer

Interventions

DRUG

JL19001, subcutaneous injection, 1 μg/kg

JL19001, subcutaneous injection, 1 μg/kg

DRUG

JL19001, subcutaneous injection, 5 μg/kg

JL19001, subcutaneous injection, 5 μg/kg

DRUG

JL19001, subcutaneous injection,10 μg/kg

JL19001, subcutaneous injection,10 μg/kg

DRUG

JL19001, subcutaneous injection,15 μg/kg

JL19001, subcutaneous injection,15 μg/kg

DRUG

JL19001, subcutaneous injection,20 μg/kg

JL19001, subcutaneous injection,20 μg/kg

DRUG

JL19001, subcutaneous injection,25 μg/kg

JL19001, subcutaneous injection,25 μg/kg

Sponsors & Collaborators

  • Jecho Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-05-31
Completion
2030-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603479 on ClinicalTrials.gov