A study evaluating the safety and efficacy of GLPG5101 (19CP02) in subjects with non-Hodgkin lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Lakefront Biotherapeutics

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Jun 2024 → ongoing

Decision date (initial)

2023-02-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Lakefront Biotherapeutics

External identifiers

EU CT number

2022-502661-23-00

EudraCT number

2021-003272-13

ClinicalTrials.gov

NCT06561425

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacodynamic, Efficacy, Others

Phase I dose-escalation phase: Evaluate the safety of GLPG5101 and determine recommended Phase 2 doses (RP2Ds)
Phase II dose expansion phase: Evaluate the efficacy of GLPG5101 in the different NHL subtypes

Secondary objectives 6

1. Evaluate safety of GLPG5101
2. Evaluate efficacy of GLPG5101
3. Evaluate GLPG5101 pharmacokinetics
4. Evaluate GLPG5101 pharmacodynamics
5. Evaluate feasibility of GLPG5101 manufacturing in r/r B-cell NHL patients
6. Evaluate health-related Quality of Life (HRQoL) (Phase II only)

Conditions and MedDRA coding

Relapsed/refractory B-cell non-Hodgkin lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Signed informed consent form
2. 2.1 Age ≥ 18 years at the time of signing informed consent form
3. 3.2 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)
4. 4.3 Relapsed or refractory disease
5. 5.2 Presence of at least one measurable lesion according to the Lugano classification (except for PCNSL subjects ineligible for ASCT after induction therapy, Cohort 6b)
6. 6. ECOG performance status of 0-2 (Subjects with ECOG 2 must have serum albumin ≥ 3.4 g/dL)
7. 7.3 & 8.1 Adequate bone marrow, renal, hepatic and pulmonary function
8. 9.1 Women of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose of conditioning chemotherapy
9. 10.1 Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception (failure rate of < 1% per year when used consistently and correctly) 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.

Exclusion criteria 11

1. 2.3 Selected prior treatments as defined in the protocol
2. 3.2 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)
3. 4.2 Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 2
4. 5.2. Active CNS involvement (lesion on contrast-enhanced CT/MRI brain, malignant B cells in CSF) by disease under study
5. 6.1 Clinically significant cardiac disease
6. 7. Primary immunodeficiency
7. 8.1 Stroke or seizure within 6 months of screening.
8. 9.1 History of autoimmune disease requiring systemic immunosuppression or disease modifying treatment within 28 days before screening
9. 10. Infection with HIV, hepatitis B or hepatitis C virus
10. 11.1 Systemic fungal, bacterial, viral, or other infection that is not controlled
11. For a complete list of Exclusion criteria, please see section 4.2 of the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase I: Incidence of (S)AEs, Dose-limiting toxicities (DLTs) until Day 28
2. Phase II: Objective response (OR) until 2 years post GLPG5101 infusion per Lugano Classification or IPCG criteria for PCNSL

Secondary endpoints 13

1. 1. Type, frequency and severity of (S)AEs (including AEs of special interest) and laboratory abnormalities
2. 2. OR until 2 years post GLPG5101 infusion per the Lugano classification (for Phase I and Cohort 6b only)
3. 3. OR until 2 years post GLPG5101 infusion per iwCLL criteria (Richter Transformation of DLBCL subtype [DLBCL-RT, Cohort 7] only)
4. 4. Complete response (CR) until 2 years post infusion per Lugano Classification, or IPCG criteria for PCNSL
5. 5. Duration of response (DOR)
6. 6. Duration of complete response (DOCR)
7. 7. Progression-free survival (PFS)
8. 8. Overall survival (OS)
9. 9. Minimal Residual Disease (MRD) negativity rate at CR (DLBCL, MCL, and DLBCL-RT)
10. 10. Levels of anti-CD19 CAR T cells in blood at peak and over time
11. 11. Levels of chemokines and cytokines in serum over time
12. 12. Proportion of successfully manufactured products within the predefined release specifications
13. 13. Change from baseline in measurement of HRQoL as assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and its CLL-specific module QLQCLL-17 (DLBCL-RT only), and EuroQol EQ-5D-5L

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Lakefront Biotherapeutics

Sponsor organisation

Lakefront Biotherapeutics

Address

Schalienhoevedreef 20t

City

Mechelen

Postcode

2800

Country

Belgium

Scientific contact point

Organisation

Lakefront Biotherapeutics

Contact name

Yuanyuan Lu, MD

Public contact point

Organisation

Lakefront Biotherapeutics

Contact name

Yuanyuan Lu, MD

Third parties 13

Locations

3 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Temporary halts 2 · Art. 38 CTR

Unexpected events 2 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 66 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications