NCT03698552

ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

A Phase I/II Study to Evaluate the Safety and Anti-Tumor Activity of ADCT-602 Targeting CD22 in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients with B-cell lymphoblastic leukemia that has come back or does not respond to treatment. Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the safety and determine the maximum tolerated dose (MTD) of ADCT-602 in patients with relapsed or refractory B-cell (B)-acute lymphoblastic leukemia (ALL) in Phase 1. II. Determine the recommended dose of ADCT-602 for Phase 2. III. Evaluate the efficacy (complete response \[CR\] with incomplete marrow recovery \[CR/CRi\] rate) of ADCT-602 in Phase 2. SECONDARY OBJECTIVES: I. Evaluate the clinical activity of ADCT-602, based on duration of response (DOR), overall survival (OS), and progression-free survival (PFS). II. Characterize the pharmacokinetic (PK) profile of ADCT-602. III. Evaluate the immunogenicity of ADCT-602. IV. Characterize the effect of ADCT-602 exposure on the QT interval. EXPLORATORY OBJECTIVES: I. Obtain preliminary data on the correlation between the clinical activity and PK profile of ADCT-602 with the baseline expression of CD22 and other cluster of differentiation (CD) markers in peripheral blood. II. Assess the impact of soluble CD22 (sCD22) on ADCT-602 PK. OUTLINE: This is a dose escalation study followed by a phase II study. Patients receive ADCT-602 intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.

Conditions

• Blasts 5 Percent or More of Bone Marrow Nucleated Cells
• CD22 Positive
• Philadelphia Chromosome Positive
• Recurrent B Acute Lymphoblastic Leukemia
• Refractory B Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	ADCT-602	Starting dose of ADCT-602: 30 μg/kg given by vein.

Timeline

• Start date: 2018-08-24
• Primary completion: 2025-11-06
• Completion: 2025-11-06
• First posted: 2018-10-09
• Last updated: 2025-12-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study