Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0JOAZB |
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| Antibody Name | Anti-CD19 antibody |
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| Antigen Name | CD19 |
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
LCB73 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible participants (≥18 years) include: Part 1 - B-cell NHL patients (excluding specific subtypes) with optional CD19 confirmation; Part 2 - confirmed CD19+ B-cell NHL (DLBCL, FL, MCL, etc.) requiring biopsy for complete response verification. All patients must have relapsed/refractory disease (≥2 prior therapies), ECOG 0-1, life expectancy ≥10 weeks, and meet contraception requirements. Part 1 allows non-measurable disease with optional biopsy; Part 2 requires measurable disease (Lugano criteria) and mandatory biopsy.
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| Administration Dosage |
Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
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| Related Clinical Trial | |||||
| NCT Number | NCT05365659 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients with Advanced B Cell Non-Hodgkin Lymphomas (NHL)
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| Primary Endpoint |
The study will determine the Recommended Dose for Expansion (RDE) in Part 1 (up to 20 months) based on DLTs and comprehensive safety data. Part 2 will assess Objective Response Rate (up to 42 months) using The Lugano Classification (Cheson 2014) for response evaluation.
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| Other Endpoint |
Immunogenicity of IKS03 (Parts 1-2) will be evaluated through ADA measurements in serum (up to 42 months). Pharmacokinetic analysis will characterize IKS03 plasma concentrations throughout the study period. The recommended Phase 2 dose (RP2D) will be determined based on antitumor activity, tolerability, and target plasma concentration achievement (up to 42 months).
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