Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies

A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00670592

Enrollment

111

Registered

2008-05-02

Start date

2008-03-31

Completion date

2013-02-28

Last updated

2020-12-17

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

Conditions

Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma

Keywords

HCD122, CD40, NHL, HL

Brief summary

This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.

Interventions

DRUGHCD122

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients may be included in the study if they meet all of the following criteria: * Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification * Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy) * Patients must be ≥ 18 years * Patients must have life expectancy \> 3 months * Patient must have adequate laboratory results * Patients must have WHO Performance Status grade 0, 1, or 2 * Patients must have at least one site of measurable disease * Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment. * Patients must be willing and able to sign the informed consent form and comply with the study protocol

Exclusion criteria

Patients will be excluded from the study if they meet any of the following criteria: * Patients who have been treated with any anti-CD40 antibody * Patients who have received prior allogeneic stem cell transplant * Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration * Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis * Women of child-bearing potential (WCBP) who are pregnant or breast feeding. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Primary endpoints (phase I) - Incidence rate of DLT and AE	2 years
Primary endpoint (phase II) - Response rate	2 years

Secondary

Measure	Time frame
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression	2 years

Countries

Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Singapore, South Korea, United Kingdom, United States

Outcome results

None listed

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