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Monoclonal Antibodies

CDX-1140 for Waldenstrom's Macroglobulinemia

Phase 1
Waitlist Available
Research Sponsored by Celldex Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8-12 weeks, starting with first dose until disease progression, assessed up to approximately 1-3 years
Awards & highlights

Study Summary

This trial is testing a new drug, CDX-1140, to see what the highest dose is that people can take without having too many side effects. They will also study how well it works when given with other drugs.

Eligible Conditions
  • Lymphoplasmacytic Lymphoma
  • Waldenstrom's Macroglobulinemia
  • Small Lymphocytic Leukemia
  • Solid Tumors
  • Ovarian Cancer
  • Head and Neck Cancers
  • B-Cell Non-Hodgkin Lymphoma
  • Peritoneal Cancer
  • Marginal Zone Lymphoma
  • MALT (Mucosa Associated Lymphoid Tissue)
  • Non-Hodgkin's Lymphoma
  • Colorectal Cancer
  • Esophageal Cancer
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Breast Cancer
  • Stomach Cancer
  • Bladder Cancer
  • Pancreatic Adenocarcinoma
  • Bile Duct Cancer
  • Liver Tumors
  • Mantle Cell Lymphoma
  • Kidney Cancer
  • Follicular Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8-12 weeks, starting with first dose until disease progression, assessed up to approximately 1-3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8-12 weeks, starting with first dose until disease progression, assessed up to approximately 1-3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of CDX-1140 as assessed by CTCAE v5.0
Secondary outcome measures
Clinical benefit rate
Duration of Response
Immunogenicity evaluation
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: CDX-1140 and pembrolizumabExperimental Treatment2 Interventions
Part 3: Eligible patients will receive CDX-1140, based on cohort assigned, in 3 week cycles until progression, or intolerance, or two years of treatment. A fixed dose of pembrolizumab will also be given in 3 week cycles.
Group II: CDX-1140 and chemotherapyExperimental Treatment2 Interventions
Part 4: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, or intolerance, or two years of treatment. Chemotherapy will also be given according to standard of care.
Group III: CDX-1140 and CDX-301Experimental Treatment2 Interventions
Part 2: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance or two years of treatment. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140.
Group IV: CDX-1140Experimental Treatment1 Intervention
Part 1: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance, or two years of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
CDX-1140
2017
Completed Phase 1
~140
Chemotherapy
2003
Completed Phase 4
~3050
CDX-301
2017
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,842 Total Patients Enrolled
Celldex TherapeuticsLead Sponsor
61 Previous Clinical Trials
3,818 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
2017. "A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03329950.
~18 spots leftby Apr 2025
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