A long-term follow-up study for patients treated with Galapagos CAR T cell therapies

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Galapagos

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Jul 2024 → ongoing

Decision date (initial)

2024-06-17

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Galapagos NV

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the long-term safety of GLPG CAR T cell products for up to 15 years post CAR T cell product infusion

Secondary objectives 2

1. To evaluate the long-term efficacy of GLPG CAR T-cell products for up to 15 years post CAR T-cell product infusion
2. To evaluate the persistence of GLPG CAR T‑cell products for up to 15 years post CAR T‑cell product infusion

Conditions and MedDRA coding

Relapsed/refractory multiple myeloma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Subject must sign and date the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any study-related procedures.
2. Subjects has been treated with a GLPG CAR T-cell therapy in a clinical trial or Managed Access Program.

Exclusion criteria 1

1. There are no exclusion criteria for this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. The type and incidence of targeted adverse events (AEs)
2. The type and incidence of serious AEs (SAEs) considered related to the GLPG CAR T-cell therapy
3. The pattern of vector integration sites, if vector sequences are detected in new malignancies, or in at least 1% of peripheral blood mononuclear cells (PBMCs)
4. The incidence of detectable replication-competent lentivirus (RCL) in peripheral blood
5. Cause-specific mortality

Secondary endpoints 4

1. Disease progression status
2. Time to subsequent anticancer therapy
3. Overall survival
4. The incidence of detectable CAR transgene in peripheral blood over time

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Galapagos

Sponsor organisation

Galapagos

Address

Generaal De Wittelaan L11 A3

City

Mechelen

Postcode

2800

Country

Belgium

Scientific contact point

Organisation

Galapagos

Contact name

Geoffrey Holder

Public contact point

Organisation

Galapagos

Contact name

Geoffrey Holder

Third parties 3

Locations

4 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

Results and documents

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

Documents 57 files

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

Application history

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