Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment and minimal preliminary biological and clinical efficacy.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HCD122 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCD122
- interventionNames
- Drug: HCD122
Primary outcomes (1)
- measure
- to determine the maximum tolerated dose (MTD)
- timeFrame
- between study Day 1 and study Day 50
Secondary outcomes (4)
- measure
- to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
- timeFrame
- between study Day 1 and study termination
- measure
- To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available