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Relapsed/Refractory B-cell Non-Hodgkin LymphomaPhase 1/2Atalanta-1NCT06561425

A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma

A Phase 1/2 study testing GLPG5101 in people with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma and Lymphomas Non-Hodgkin&Amp;Amp;#39;s B-Cell, run by Lakefront Biotherapeutics NV at 11 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use. This study will be carried out in 2 phases: The first phase is to see which doses of GLPG5101 work best with the least number of side effects. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GLPG5101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
11 sitesin 4 countries
Study dates
9 Mar 2022to 27 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of one of the following NHL subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, MCL, BL, PCNSL, DLBCL-RT, High Grade B-cell Lymphoma (HGBL), CLL/SLL
  • Relapsed or refractory disease
  • Presence of at least one measurable lesion according to the Lugano classification (except for PCNSL subjects ineligible for ASCT after induction therapy, Cohort 6b; and except for CLL/SLL subjects without a measurable lesion or a PET positive lesion will be eligible if they have splenomegaly (spleen size >13 cm) and bone marrow infiltration with lymphoma)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Participants with ECOG 2 must have serum albumin ≥ 3.4 gram/deciliter)
  • Adequate bone marrow function
  • Adequate renal, hepatic and pulmonary function
  • Women of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose of conditioning chemotherapy
  • Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception and agree to remain on a highly effective method of contraception from the time of signing the informed consent form until at least 12 months after GLPG5101 infusion. Subjects must agree to not donate eggs or sperm during this period.

Who cannot join

  • Selected prior treatments as defined in the protocol
  • History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 3 years. (exceptions per protocol)
  • Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 2
  • Active central nervous system (CNS) involvement (lesion on contrast-enhanced CT/MRI brain, malignant B cells in CSF) by disease under study (exceptions per protocol)
  • Clinically significant cardiac disease
  • Primary immunodeficiency
Show all 10Show fewer
  • Stroke or seizure within 6 months of screening
  • History of autoimmune disease requiring systemic immunosuppression or disease modifying treatment within 28 days before screening
  • Infection with human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C virus
  • Systemic fungal, bacterial, viral, or other infection that is not controlled

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

Belgium5 sites

  • Antwerp University Hospital

    Edegem, 2650

  • UZ Leuven

    Leuven, 3000

  • CHU De Liège

    Liège, 4000

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Netherlands3 sites

  • Academisch Medisch Centrum (Amsterdam UMC)

    Amsterdam, 1105 AZ

  • Leiden University Medical Center

    Leiden, 2333 ZA

  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

    Rotterdam, 3015 GD

Other trials in Netherlands

United States2 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

Finland1 site

  • Helsingin Yliopistollinen Sairaala (HUS)

    Helsinki, 00029

Other trials in Finland

About this study

Official title: A Phase I/II, Multicenter Study Evaluating the Feasibility, Safety, and Efficacy of Point-of-care Manufactured GLPG5101 (19CP02) in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use.

This study will be carried out in 2 phases:

  • The first phase is to see which doses of GLPG5101 work best with the least number of side effects.
  • In the second phase, participants will receive the selected dose(s) based on the results in the first phase.
Read the detailed description

Phase 1 Dose escalation phase:

The dose escalation phase is designed to select the doses for dose expansion based on efficacy and safety outcomes.

Three dose levels of GLPG5101 will be evaluated to determine the recommended phase 2 doses (RP2Ds).

Participants with aggressive or indolent forms of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (r/r NHL) including follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and Diffuse large B-cell lymphoma (DLBCL) will be enrolled. In case any safety or efficacy differences based on histological subtype of the disease are observed, it may be decided to make decisions regarding dose escalation for a specific subtype(s) independently, upon recommendation by the Safety Review Committee (SRC). Hence the RP2Ds may be different for different subtypes.

Phase 2 Dose expansion phase:

After determination of the RP2Ds, the study continues with the dose expansion phase. Different doses deemed safe by the SRC within the same indication may be explored in the dose-expansion phase to help select the optimal dose for further development.

During this phase, participants will be enrolled into separate disease cohorts as defined by their NHL subtype:

  • Cohort 1a: DLBCL second line or greater (2L+)
  • Cohort 1b: DLBCL 2L+ with secondary central nervous system lymphoma (SCNSL)
  • Cohort 2: High-risk first-line DLBCL
  • Cohort 3: Indolent B-cell NHL (FL and MZL third-line or greater [3L+])
  • Cohort 4: MCL 2L+
  • Cohort 5: BL 2L+
  • Cohort 6a: PCNSL 2L+
  • Cohort 6b: PCNSL first-line consolidation
  • Cohort 7: DLBCL-RT 2L+
  • Cohort 8: CLL/SLL (r/r)

Participants per disease cohort will be treated at the selected RP2Ds for that disease subtype.

Being tested
GLPG5101
Keywords
non-Hodgkin lymphoma (NHL), Follicular lymphoma (FL), Marginal zone lymphoma (MZL), Mantle cell lymphoma (MCL), Burkitt lymphoma (BL), Primary central nervous system lymphoma (PCNSL), Diffuse large B-cell lymphoma (DLBCL), CAR T-cell therapy, Diffuse large B-cell lymphoma - Richter Transformation (DLBCL-RT), small lymphocytic leukemia (SLL), chronic lymphocytic leukemia (CLL)
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLPG5101Genetic

    Also called 19CP02

    Autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy

Study groups in NCT06561425
Study groupRoleWhat they receive
Phase 1 (Dose escalation phase): Dose level 1ExperimentalParticipants will receive a single dose of GLPG5101 intravenous (IV) cell suspension for infusion at dose level 1 on Day 0.
Receives: Genetic: GLPG5101
Phase 1 (Dose escalation phase): Dose level 2ExperimentalParticipants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 2 on Day 0.
Receives: Genetic: GLPG5101
Phase 1 (Dose escalation phase): Dose level 3ExperimentalParticipants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 3 on Day 0.
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 1a: DLBCL 2L+ExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 1b: DLBCL 2L+ SCNSLExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 2: High-risk first-line DLBCLExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 3: Indolent B-cell NHL (FL and MZL 3L+)ExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 4: MCL 2L+ExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 5: BL 2L+ExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 6a: PCNSL 2L+ExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 6b: PCNSL first-line consolidationExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Phase 2 (Dose expansion phase): Cohort 7: DLBCL-RT 2L+ExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101
Experimental: Phase 2 (Dose expansion phase): Cohort 8 CLL/SLL (r/r)ExperimentalParticipants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0
Receives: Genetic: GLPG5101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Measured: 2 years

  2. Phase 1: Number of participants with Dose-Limiting Toxicities (DLTs)

    Measured: From first dose up to Day 28

  3. Phase 2: Number of participants with objective response (OR) per the Lugano Classification or International Primary central nervous system lymphoma Collaborative Group (IPCG) criteria for PCNSL or per iwCLL (CLL [Cohort 8] and DLBCL-RT [Cohort 7] only)

    For all cohorts

    Measured: 2 years

Secondary outcomes (15)

  1. Phase 2: Number of participants with AEs and SAEs

    Measured: 2 years

  2. Number of participants with AEs of special interests

    Measured: 2 years

  3. Number of participants with OR per the Lugano Classification or IPCG criteria

    For phase 1 and cohort 6b only

    Measured: 2 years

  4. Number of participants with OR per International workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria (DLBCL-RT [cohort 7] only

    Measured: 2 years

  5. Number of participants with complete response (CR) per Lugano Classification or IPCG criteria for PCNSL or per iwCLL (CLL [Cohort 8] and DLBCL-RT [Cohort 7] only)

    Measured: 2 years

  6. Duration of response (DOR)

    Measured: 2 years

  7. Duration of complete response (DOCR)

    Measured: 2 years

  8. Progression-free survival (PFS)

    Measured: 2 years

  9. Overall survival (OS)

    Measured: 2 years

  10. Number of participants without minimal Residual Disease (MRD) at CR (DLBCL, MCL, DLBCL-RT, and CLL/SLL)

    Measured: 2 years

  11. Pharmacokinetics (PK): Levels of anti-CD19 CAR T cells in blood at peak and over time

    Measured: 2 years

  12. Pharmacodynamics (PD): Levels of chemokines in serum over time

    Measured: Day 7 before infusion, Day 0, Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28

  13. PD: Levels of cytokines in serum over time

    Measured: Day 7 before infusion, Day 0, Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28

  14. Percentage of successfully manufactured GLPG5101 products within the predefined release specifications

    Measured: From leukapheresis to infusion

  15. Phase 2: Change from baseline in measurement of HRQoL using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and its CLL-specific module QLQ-CLL-17 (DLBCL-RT and CLL only), and EuroQol EQ-5D-5L

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start9 Mar 2022
  3. Primary completion27 May 2026
  4. Study completion27 May 2026

Why it stopped: Following the decision by Galapagos NV to wind down its cell therapy programs, the study was early terminated at the end of the study treatment period for the last subject (27-May-2026).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561425
Sponsor's protocol ID
CP0201-NHL
Other IDs
2022-502661-23-00
Acronym
Atalanta-1
Status last verified
Jun 2026
First submitted
16 Aug 2024
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kersten MJ, Kuipers MT, Mutsaers PGNJ, Willems E, Saevels K, Dreyling M, Jacobson C, Bishop MR, Zandvliet M, Milatos S, Lobetti-Bodoni C, Blum S, Van Hoorde K, Desai J, Acciarri L, Pont MJ, van Muyden A, Fasan O, Vermaat JSP, Anguille S. CD19 CAR T-cell therapy (GLPG5101) for relapsed or refractory B-cell non-Hodgkin lymphoma (ATALANTA-1): phase 1 results from a single-arm, multicentre, phase 1/2 study. Lancet Haematol. 2026 Sep;13(9):e648-e659. doi: 10.1016/S2352-3026(26)00192-4.

    PubMed 42660131

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GLPG5101 in people with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma and Lymphomas Non-Hodgkin&Amp;Amp;#39;s B-Cell, run by Lakefront Biotherapeutics NV at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium, Netherlands, United States, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Following the decision by Galapagos NV to wind down its cell therapy programs, the study was early terminated at the end of the study treatment period for the last subject (27-May-2026).). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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