546 Participants NeededMy employer runs this trial

CAR T-cell Therapy for Blood Cancers

(Hesperia Trial)

Recruiting at 12 trial locations
GM
LB
Overseen ByLakefront Biotherapeutics Medical Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Galapagos NV
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to follow up with individuals who have already received a specific CAR T-cell therapy for blood cancers. The goal is to assess the long-term safety and effectiveness of the treatment over 15 years after the last infusion. Researchers will monitor for any delayed side effects and evaluate the ongoing effectiveness of the treatment. Individuals previously treated with Galapagos CAR T-cell therapy may be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential approval of a promising treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that GLPG CAR T-cell therapy could effectively treat blood cancers. Studies have found that this treatment leads to high rates of complete response in patients who have tried other treatments. Many patients experience a significant decrease in cancer cells after receiving the therapy.

Regarding safety, data from past studies on similar CAR T-cell therapies, such as GLPG5101 and GLPG5201, indicate that the treatment is generally well-tolerated. Most patients do not experience severe side effects. However, some side effects, like fever or low blood pressure, can occur but are usually manageable with medical care.

Long-term safety studies, such as the HESPERIA study, are ongoing to monitor any delayed side effects over 15 years. These studies aim to ensure that the therapy remains safe and effective over time. Overall, current evidence supports GLPG CAR T-cell therapy as a promising and safe option for many patients with blood cancers.12345

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for blood cancers, which often include chemotherapy and radiation, GLPG CAR T-cell therapy uses a cutting-edge approach by modifying a patient's own T-cells to better target and attack cancer cells. This therapy offers a new mechanism of action by reprogramming the immune system to recognize and destroy cancer more effectively. Researchers are excited because this personalized treatment has the potential to provide long-lasting remission with fewer side effects compared to traditional therapies.

What is the effectiveness track record for GLPG CAR T-cell therapy in treating blood cancers?

Studies have shown that CAR T-cell therapy is a strong option for treating blood cancers. This therapy uses specially modified immune cells to locate and destroy cancer cells. In this trial, participants will receive Galapagos (GLPG) CAR T-cell therapy. Research indicates that patients treated with GLPG CAR T-cell therapies often experience complete cancer remission after treatment. Additionally, long-term data demonstrate that these positive outcomes can persist. This suggests that GLPG CAR T-cell therapy could effectively treat blood cancers, with evidence of strong and lasting results.13467

Who Is on the Research Team?

LB

Lakefront Biotherapeutics Study Director

Principal Investigator

Lakefront Biotherapeutics NV

Are You a Good Fit for This Trial?

This study is for people who have already received Galapagos CAR T-cell therapy for blood cancers, either in a clinical trial or through special access programs.

Inclusion Criteria

I have received Galapagos CAR T-cell therapy in a trial or access program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Galapagos CAR T-cell therapy

Not specified

Long-term Follow-up

Participants are monitored for long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion

15 years

What Are the Treatments Tested in This Trial?

Interventions

  • GLPG CAR T-cell therapy

Trial Overview

The study monitors patients for up to 15 years after receiving GLPG CAR T-cell therapy to check long-term safety and effectiveness, including any delayed side effects or risks from the treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Previously treated participants with GLPG CAR T-cell therapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Galapagos NV

Lead Sponsor

Trials
140
Recruited
23,500+
Dr. Walid Abi-Saab profile image

Dr. Walid Abi-Saab

Galapagos NV

Chief Medical Officer since 2017

MD from the American University of Beirut, specialization in Internal Medicine and Rheumatology

Dr. Paul Stoffels profile image

Dr. Paul Stoffels

Galapagos NV

Chief Executive Officer since 2022

MD from the University of Antwerp, specialization in Infectious Diseases and Tropical Medicine at the Institute of Tropical Medicine in Antwerp

Galapagos Cell Therapeutics NV

Lead Sponsor

Lakefront Biotherapeutics NV

Lead Sponsor

Citations

CAR-T cell therapy for hematological malignancies - PMC - NIH

Chimeric antigen receptor (CAR) recognizes tumor-associated antigens and kills tumor cells. CAR-T has achieved good results in the treatment of hematological ...

Galapagos Snags FDA RMAT Designation for R/R Mantle ...

The study is assessing the long-term safety and efficacy of patients treated with Galapagos CAR T-cell products over 15 years post treatment.

Long-term Follow-up of Participants Treated With Galapagos ...

The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess ...

Galapagos to Present Results of Pioneering Innovation in ...

New Phase 1/2 data support the potential of our CAR T-cell therapy candidates, GLPG5101 and GLPG5201, in addressing unmet needs for patients ...

CD19 -targeted CAR T therapy treating hematologic ...

Conclusion. CAR-T-cell therapy is an effective treatment option for patients with hematologic malignancies, with long-term data demonstrating strong efficacy ...

Galapagos' HESPERIA Study Tracks Long-Term Follow-Up ...

The study is assessing the long-term safety and efficacy of patients treated with GLPG CAR-T products over a period of 15 years posttreatment.

Durable Responses With GLPG5101 Suggest Feasibility of ...

Treatment with GLPG5101 led to high complete response (CR) rates across all indications in heavily pretreated patients with relapsed/refractory non-Hodgkin ...