Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Sep 2022 → ongoing

Decision date (initial)

2023-10-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Janssen Research & Development, LLC

External identifiers

EU CT number

2023-505530-10-00

EudraCT number

2020-005521-84

ClinicalTrials.gov

NCT05201781

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.

Secondary objectives 1

1. To collect additional long-term data on replication competent lentivirus (RCL), cilta-cel persistence, efficacy, and overall survival

Conditions and MedDRA coding

Multiple Myeloma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. All subjects who received cilta-cel in a Company-sponsored clinical study are candidates for Study MMY4002. The inclusion criteria for the study are described below: 1. Subjects who have received at least one dose of cilta-cel in a Company-sponsored clinical study.
2. 2. Subjects who have provided informed consent for Study MMY4002.

Exclusion criteria 1

1. No exclusion criteria are applicable in this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Number of subjects with delayed adverse events associated with administration of Cilta-cel. The following adverse events will be collected: - New malignancies and recurrence of preexisting malignancy (all grades)
2. - New incidence or exacerbation of a preexisting neurologic disorder (all grades)
3. - New incidence or exacerbation of a preexisting rheumatologic or other autoimmune disorder (all grades)
4. - New incidence of Grade ≥3 hematologic disorder including hypogammaglobulinemia (Years 1-5).Serious hematologic disorder including hypogammaglobulinemia (Years 6-15).
5. - New incidence of Grade ≥3 infection (Years 1-5).Serious infection(Years 6-15).
6. - All SAEs (Years 1-5). Only related SAEs as assessed by the Investigator (Years 6-15).

Secondary endpoints 5

1. - Number of subjects with measurable RCL in peripheral blood.
2. - Number of subjects with CAR transgene level >lower limit of quantitation (LLOQ) in peripheral blood cells.
3. - Assessment of the pattern of lentiviral vector integration sites if at least 1% of cells in the blood sample or new malignancy are positive for vector sequences.
4. - Long term follow-up on CAR-T therapy efficacy if the subject does not have confirmed disease progression or does not initiate subsequent antimyeloma therapy at the entry of the study and at any time of during the study.
5. - Overall Survival (OS)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS point of Contact

Third parties 2

Locations

4 EU/EEA countries · 9 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 24 files

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

Application history

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