Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy

An Open-label,Multi-center, Phase l/ll Study of Anti-CD40 Monoclonal Antibody (HCD122) Administered Intravenously to Subjects With Advanced Chronic Lymphocytic Leukemia That is Refractory or Relapsed After at Least One Previous Fludarabine-containing Chemotherapy Regimen

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00108108

Enrollment

Registered

2005-04-15

Start date

2005-04-30

Completion date

2008-06-30

Last updated

2012-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Lymphocytic Leukemia

Brief summary

The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.

Interventions

DRUGHCD122

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of CLL requiring treatment * Refractory or relapsed disease * Prior treatment with fludarabine * Male or Female * \>18 years of age

Exclusion criteria

* Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months. * Clinically significant cardiac dysfunction or other significant organ dysfunction Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.

Design outcomes

Primary

Measure	Time frame
to determine the maximum tolerated dose (MTD)	between study Day 1 and study Day 50

Secondary

Measure	Time frame
to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients	between study Day 1 and study termination
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients	between study Day 1 and study termination
To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients	between study Day 1 and study termination
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients	between study Day 1 and study termination

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026