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GLPG5101 for Non-Hodgkin's Lymphoma (Atalanta-1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Galapagos NV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of one of the following NHL subtypes: Aggressive DLBCL, FL grade 1, 2 or 3A, MZL, or MCL, BL, PCNSL
Relapsed or refractory disease
Must not have
Richter's transformation
Infection with human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C virus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to determine if a new treatment called GLPG5101 can effectively treat non-Hodgkin lymphoma (NHL) and is safe to use. The study will be conducted in

Who is the study for?
This clinical trial is for individuals with various types of non-Hodgkin lymphoma, specifically B-cell lymphomas. Participants should meet certain health criteria to be eligible, but specific inclusion and exclusion details are not provided.
What is being tested?
The study tests GLPG5101's effectiveness and safety in treating non-Hodgkin lymphoma. It has two phases: the first determines the optimal dose with minimal side effects; the second gives all participants this best dose.
What are the potential side effects?
While specific side effects are not listed, they will be monitored to determine the safest dosage of GLPG5101 during phase one of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is a specific type of non-Hodgkin lymphoma.
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My condition has returned or didn't respond to treatment.
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I can care for myself and my albumin levels are adequate if I'm less active.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition has transformed into a more aggressive form of cancer.
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I do not have active HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

9Treatment groups
Experimental Treatment
Group I: Phase 2 (Dose expansion phase): PCNSLExperimental Treatment1 Intervention
Participants with PCNSL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.
Group II: Phase 2 (Dose expansion phase): MCLExperimental Treatment1 Intervention
Participants with MCL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.
Group III: Phase 2 (Dose expansion phase): Indolent B-cell NHLExperimental Treatment1 Intervention
Participants with indolent B-cell NHL (FL and MZ) will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.
Group IV: Phase 2 (Dose expansion phase): High-risk DLBCLExperimental Treatment1 Intervention
Participants with High-risk DLBCL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.
Group V: Phase 2 (Dose expansion phase): DLBCLExperimental Treatment1 Intervention
Participants with DLBCL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.
Group VI: Phase 2 (Dose expansion phase): BLExperimental Treatment1 Intervention
Participants with BL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.
Group VII: Phase 1 (Dose escalation phase): Dose level 3Experimental Treatment1 Intervention
Participants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 3 on Day 0.
Group VIII: Phase 1 (Dose escalation phase): Dose level 2Experimental Treatment1 Intervention
Participants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 2 on Day 0.
Group IX: Phase 1 (Dose escalation phase): Dose level 1Experimental Treatment1 Intervention
Participants will receive a single dose of GLPG5101 intravenous (IV) cell suspension for infusion at dose level 1 on Day 0.

Find a Location

Who is running the clinical trial?

Galapagos NVLead Sponsor
138 Previous Clinical Trials
22,751 Total Patients Enrolled
Galapagos Study DirectorStudy DirectorGalapagos NV
23 Previous Clinical Trials
13,020 Total Patients Enrolled
~127 spots leftby May 2029
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