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En studie for å evaluere uønskede hendelser og endring i sykdomsaktiviteten til subkutan (SC) epcoritamab som monoterapi eller kombinert med standardbehandlingsterapier hos voksne deltakere i Kina med B-celle non-Hodgkin lymfom

2. november 2026 oppdatert av: Genmab

Fase 1b/2, åpen studie for å evaluere sikkerhet og foreløpig effekt av Epcoritamab som monoterapi eller kombinert med standardbehandlinger hos kinesiske personer med B-celle non-Hodgkin lymfom

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy [Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China.

In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

49

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100071
        • The Fifth Medical Center of PLA General Hospital /ID# 230520
      • Beijing, Beijing Municipality, Kina, 100191
        • Peking University Third Hospital /ID# 228138
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Fujian Medical University Union Hospital /ID# 231890
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Sun Yat-Sen University Cancer Center /ID# 228033
      • Guangzhou, Guangdong, Kina, 510080
        • Guangdong Provincial People's Hospital /ID# 228028
      • Guangzhou, Guangdong, Kina, 510515
        • Nanfang Hospital of Southern Medical University /ID# 227916
    • Henan
      • Zhengzhou, Henan, Kina, 450008
        • Henan Cancer Hospital /ID# 228772
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221
    • Hunan
      • Changsha, Hunan, Kina, 410006
        • Hunan Cancer Hospital /ID# 231859
    • Jiangsu
      • Suzhou, Jiangsu, Kina, 215006
        • The First Affiliated Hospital of Soochow University /ID# 228024
      • Xuzhou, Jiangsu, Kina, 221006
        • The Affiliated Hospital of Xuzhou Medical College /ID# 228774
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 228771
      • Nanchang, Jiangxi, Kina, 330029
        • Jiangxi Provincial Cancer Hospital /ID# 231944
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital, Sichuan University /ID# 231434
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300000
        • Tianjin Cancer Hospital /ID# 228135
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer hospital /ID# 228776

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

All Cohorts:

  • Life expectancy of >= 3 months on standard of care (SOC).

  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2.

  • Has one or more measurable disease sites:

    • Fluorodeoxyglucose-positron emission tomography (FDGPET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites.
    • >= 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 cm) or >= 1.0 measurable extra-nodal lesion (long axis >= 1 cm) on CT scan or MRI. Note: A previously irradiated lesion must have demonstrated progression or residual disease in the lesion after radiotherapy to be considered measurable.

Cohort 1 Part 1 (Monotherapy Safety Run-in) Specific Criteria:

  • Must have histologically confirmed CD20+ Diffuse large B-cell lymphoma (DLBCL), or High-grade B-cell lymphoma (HGCBL) with MYC and BCL2 and/or BCL6 translocations and DLBCL feature, and follicular Lymphoma (FL) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 (or later) classification.
  • Must have at least one prior treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
  • Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (<6 months) of completion of therapy.

Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria:

  • Must have histologically confirmed CD20+ DLBCL at most recent (previous or current) representative tumor biopsy based on the pathology report, inclusive of the following according to the World Health Organization (WHO) 2016 (or later) classification.

    • DLBCL, not otherwise specified (NOS) including de novo or histologically transformed from an earlier diagnosis of indolent lymphoma such as FL and nodal marginal zone lymphoma with a subsequent development of DLBCL relapse or.
    • "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Double- /triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible.
    • FL Grade 3B.

  • Following safety run-in and up to the 12th participant (including the number of safety run-in participants) in Cohort 1, participants must have received at least 1 prior line of systemic therapies which must include an anti-CD20 monoclonal antibody containing combination therapy (e.g., rituximab). After safety run-in confirms tolerability of the full dose A of epcoritamab, participants must have received at least 2 prior lines of systemic therapies.

  • Must have either failed prior autologous HSCT, or be ineligible for autologous HSCT due to age, comorbidities, performance status, comorbidities, or insufficient response to prior treatment.

  • Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (< 6 months) of completion of therapy.

Cohort 2 Specific Criteria:

  • Must have newly diagnosed CD20+ DLBCL.

  • Must have one of the following histologically confirmed CD20+ DLBCL (de novo or histologically transformed from FL at most recent (previous or current) representative tumor biopsy based on the pathology report including one of the following diagnoses according to the WHO 2016 (or later) classification:

    • DLBCL, not otherwise specified (NOS);
    • "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations) Note: Double-/triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible or;
    • FL Grade 3B

  • Eligible for standard R-CHOP for 6 cycles.

Cohort 3 Specific Criteria:

  • Must have histologically confirmed CD20+ Grade 1 - 3a Follicular Lymphoma stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma at most recent (previous or current) representative tumor biopsy and based on the pathology report, according to the WHO 2016 (or later) classification.
  • Must have R/R disease to at least one prior systemic anti-lymphoma treatment which must include an anti CD20 monoclonal antibody (e.g., rituximab). Participant who received only prior anti-CD20 monoclonal antibody monotherapy is not eligible. Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response or progressed within 6 months (< 6 months) of completion of therapy.
  • Must be eligible for R2 per investigator determination.
  • Willing to take aspirin prophylaxis (participants with low or intermediate risk for thromboembolism) or prophylactic anticoagulant (if high risk for a thromboembolic event) (lenalidomide treated participants only).

Exclusion Criteria:

All Cohorts:

  • History of primary mediastinal lymphoma.
  • Autologous Stem Cell Transplantation within 100 days prior to enrollment.
  • Have received prior allogeneic hematopoietic stem cell transplantation at any time.
  • Have been treated with a bispecific antibody targeting CD3 and CD20.

Cohort 2 Specific Criteria:

- History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1 Part 1: Epcoritamab Monotherapy

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Legemiddel: Epcoritamab

Subcutaneous Injection (SC)

Andre navn:
  • ABBV-GMAB-3013
Eksperimentell: Cohort 1 Part 2: Epcoritamab Expansion

Participants will receive SC epcoritamab in 28 day cycles.
Legemiddel: Epcoritamab

Subcutaneous Injection (SC)

Andre navn:
  • ABBV-GMAB-3013
Eksperimentell: Cohort 2: Epcoritamab + RCHOP

Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, IV injected cyclophosphamide, IV infused doxorubicin, IV infused vincristine, and oral prednisone (R-CHOP)] in 21 day cycles followed by 28 day cycles.
Legemiddel: Epcoritamab

Subcutaneous Injection (SC)

Andre navn:
  • ABBV-GMAB-3013
Legemiddel: Cyclophosphamide

IV Injection

Legemiddel: Rituximab

Intravenous (IV) Infusion

Legemiddel: Doxorubicin

IV Infusion

Legemiddel: Vincristine

IV Infusion

Legemiddel: Prednisone

Oral; Tablet
Eksperimentell: Cohort 3: Epcoritamab + R2

Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, and oral lenalidomide (R2)] in 28 day cycles.
Legemiddel: Epcoritamab

Subcutaneous Injection (SC)

Andre navn:
  • ABBV-GMAB-3013
Legemiddel: Rituximab

Intravenous (IV) Infusion

Legemiddel: Lenalidomide

Oral; Capsule

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)
Tidsramme: Up to Approximately 5 Years

Best overall response (BOR) is defined as the percentage of participants in Cohort 1 Part 2 third line plus (3L) R/R DLBCL who achieved best overall response of complete response (CR) or partial response (PR) by Lugano 2014 criteria as assessed by independent review committee (IRC).
Up to Approximately 5 Years
Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)
Tidsramme: Up to Approximately 5 Years

DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Up to Approximately 5 Years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)
Tidsramme: Up to Approximately 5 Years

CR is defined as the absence of lymphoma determined by Lugano 2014 criteria as assessed by IRC.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)
Tidsramme: Up to Approximately 5 Years

PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)
Tidsramme: Up to Approximately 5 Years

OS is defined for Cohort 1 epcoritamab monotherapy participants, as the time in months from first dose of epcoritamab to death from any cause.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)
Tidsramme: Up to Approximately 5 Years

DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)
Tidsramme: Up to Approximately 5 Years

TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by IRC.
Up to Approximately 5 Years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Genmab

Samarbeidspartnere

AbbVie

Etterforskere

  • Studieleder: ABBVIE INC., AbbVie

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. mars 2022

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

18. januar 2022

Først innsendt som oppfylte QC-kriteriene

20. januar 2022

Først lagt ut (Faktiske)

21. januar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • M21-103

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD-delingstidsramme

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Tilgangskriterier for IPD-deling

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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Abonnere