- Clinical Trials
GCT3013-03 – Trial of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20)
For the Genmab clinical trial; “A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome – Protocol GCT3013-03 (as further described in the Participant Information Sheet and Consent Form provided to you as trial participant.
1) DATA CONTROLLER
The entity responsible for the processing of your personal data is:
Genmab A/S (CVR no. 21023884)
Kalvebod Brygge 43,
DK-1560 Copenhagen V
Please note, We recommend that you liaise with the Investigator or researchers if you have any questions to the processing of your personal data. The Investigator or researchers will direct your requests as needed by using your study subject ID to Us. It is recommended to use this approach as this will ensure that your request will be dealt with in the most confidential way and your identity does not need to be revealed to Us. If you feel that the Investigator or researchers are unable to address any question you have about the processing of your personal data and your rights, you can contact our Data Protection Officer at: [email protected]. You also have the right to lodge a complaint with the data protection regulator if you think that any of your rights have been violated.
Information on Genmab A/S’s use of your personal data
As mentioned in the Participant Information Sheet and Consent Form, your personal data will be disclosed to the sponsor’s parent company Genmab A/S. Genmab A/S will take all reasonable steps to keep your personal data and identity confidential. Your personal data and your identity will never be made public.
Genmab A/S will ensure that your personal data is handled according to the Danish law and the European Union data protection law. The following explains:
- which personal data Genmab A/S will receive
- how Genmab A/S will use this data and for what purpose
- your rights when Genmab A/S handles your personal data
The collection and use of your personal data
Genmab A/S will collect and store the following personal data about you:
- Your sex, age, year of birth, body weight, and height.
- Your race and ethnicity
- Your medical data including your medical history, scans, blood samples, biopsies and genetic data
- Your health status
- Information about your use of the study drug
- Information about the effect the study drug has on you and its potential side effects
Only the study doctor will collect your name, contact details, and Medicare number (if applicable). The information will be stored in the clinic and will never be sent to Genmab A/S or any third parties.
The purpose of collecting and processing your personal data is to establish the safety and tolerability of epcoritamab in patients with refractory chronic lymphocytic leukemia (CLL) or Richter´s syndrome (RS). The results of this research project may be used to apply for a license to market epcoritamab. You can read more about the purpose of the trial in this Participant Information Sheet and Consent Form under the section “What is the purpose of this research?”
The processing of your personal data is needed in order for Genmab A/S to comply with legal obligations. These obligations include notifications to the regulatory authorities and archiving, for example to ensure your safety. The legal basis for such processing of your personal data is described in art. 6 (1) (c) and art. 9 (2) (i) of “GDPR.”1 Further, Genmab has a legitimate purpose in collecting and using your personal data for scientific research purposes. The legal basis for such processing of your personal data is described in art. 6 (1) (f) and art. 9 (2) (j) of the GDPR.2
You should notify the study doctor <insert name of trial doctor> or study staff at <insert phone no.> if you withdraw from the research project. Your personal data already collected will still be used. After your withdrawal, no new personal data will be collected or processed for the research project unless it relates to an already reported side effect. Your medical record may be examined if a side effect occurs.
Disclosure of your information to third parties
Genmab may share your personal data with other companies and organizations subject to confidentiality. This includes Genmab’s collaboration partner Abbvie Deutschland GmbH & Co and other companies within the AbbVie group, and the following categories of data processors: contract research organizations, such as IQVIA, laboratories, and IT suppliers. Such companies and organizations work for or with Genmab A/S to develop epcoritamab and may only use your personal data for the purposes described in the Subject Information and Informed Consent Form and will only receive your personal data in a coded form.
Genmab’s authorized representatives, such as auditors and monitors may review your personal data including your medical record to verify that the research project is being run correctly. Genmab A/S’s Genomic Data Review Committee will review the genomic data generated throughout the research project. In some situations, it may be required to access data remotely where it is not feasible for auditors and monitors to travel to or access the study center in person to verify the data. By signing the informed consent form, you accept such remote access if allowed by local regulations. In addition, members of the Independent Ethics Committee and representatives of the regulatory authorities from your country of residence or from other countries may review your personal data including your medical record to verify that the trial is being run according to the protocol and your rights and safety are protected.Genmab may also share your personal data with third parties if required by law. An example would be if Genmab must disclose your personal data to comply with any legal obligation or to establish, exercise or defend Genmab A/S’s legal rights.
Information about this trial can be found on public websites around the world. This corresponds with Genmab A/S’s commitment for transparency of our clinical research and with applicable laws and regulations. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Transfer of your personal data outside of the European Economic Area (‘EEA’)
Your personal data may be transferred within the EEA or to countries outside the EEA, including the United States. The data protection laws in countries outside of EEA may not be as strict as in the EEA. However, Genmab A/S will ensure compliance with EU data protection law; Genmab A/Swill ensure that the recipient country is an adequate country (i.e. that the country in question is recognized as having an equivalent level of protection). If the country is not an adequate country, Genmab A/S will ensure to put appropriate safeguards in place when transferring your personal data e.g in accordance with Chapter V art. 46, (2) (c) of the GDPR. Genmab A/S uses EU standard contractual clauses to safeguard such transfer.
Retention of personal data
Genmab A/S will save your personal data in accordance with the regulation (EU) 2014/536 of 16 April 2014 (on clinical trials on medicinal products for human use) unless other EU law requires archiving for a longer period. Genmab A/S will archive the content from the clinical trial master file for at least for the product lifetime plus 25 years after the end of the clinical trial.
You have a number of legal rights in relation to the personal data that Genmab A/S holds about you. These rights include:
- You are entitled to ask for up-to-date information on:
- which personal data have been recorded
- how the personal data has been recorded
- to see personal data relating to you
- to have personal data relating to you corrected if it is inaccurate
- Your participation in the trial is voluntary. Your choice will not affect your present or future treatment.
- The right to receive the personal data collected about you in a structured, commonly used, and machine-readable format
- The right to request that Genmab A/S provides those data to a third party where this is technically feasible
- The right to strict confidentiality when your personal data is used/processed.
- The right to request that Genmab A/S erases your personal data in certain circumstances.
- The right to request that the processing of your personal data is restricted in certain circumstances.
- The right to lodge a complaint with the data protection regulator if you think that any of your rights have been violated.
Please note there may be conditions or limitations on these rights. You may for example not have the right to restricted use of your personal data if Genmab A/S needs to manage your information in specific ways in order for the research to be reliable and accurate.
If you have any questions about this information, please contact your study doctor via the information given in the Participant Information Sheet and Consent Form. The study doctor will direct your requests as needed by using your trial patient ID to Genmab A/S. This approach is recommended to ensure that your request will be dealt with in the most confidential way as your identity does not need to be revealed to sponsor or Genmab A/S.
You can always contact Genmab A/S’s Data Protection Officer at: [email protected] Genmab A/S, (CVR no. 21023884); Kalvebod Brygge 43; DK-1560 Copenhagen V; Denmark; www.genmab.com if you feel that the study doctor is unable to address any question you have about Genmab A/S processing of your personal data and your rights, or if you want to file a complaint regarding Genmab A/S’s processing of your personal data. You also have the right to lodge a complaint with the data protection regulator if you think that any of your rights have been violated.
1. Regulation (EU) 2016/679 of the European Parliament and of the council of 27 April 2016 referred to as the GDPR;
Last updated: March 2023