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B-Cell Non-Hodgkin LymphomaPhase 1/2NCT05201248

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma

A Phase 1/2 study testing Epcoritamab, Cyclophosphamide and Rituximab in people with B-Cell Non-Hodgkin Lymphoma, run by Genmab at 18 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Non-Hodgkin Lymphoma
What is being tested?
Epcoritamab, Cyclophosphamide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
18 sitesChina
Study dates
10 Mar 2022to Sep 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 30Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • The Fifth Medical Center of PLA General Hospital /ID# 230520

    Beijing, Beijing Municipality, 100071

  • Peking University Third Hospital /ID# 228138

    Beijing, Beijing Municipality, 100191

  • Hunan Cancer Hospital /ID# 231859

    Changsha, Hunan, 410006

  • West China Hospital, Sichuan University /ID# 231434

    Chengdu, Sichuan, 610041

  • Fujian Medical University Union Hospital /ID# 231890

    Fuzhou, Fujian, 350001

  • Sun Yat-Sen University Cancer Center /ID# 228033

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial People's Hospital /ID# 228028

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University /ID# 227916

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer hospital /ID# 228776

    Hangzhou, Zhejiang, 310022

  • The First Affiliated Hospital of Nanchang University /ID# 228771

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital /ID# 231944

    Nanchang, Jiangxi, 330029

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724

    Shanghai, Shanghai Municipality, 200065

  • The First Affiliated Hospital of Soochow University /ID# 228024

    Suzhou, Jiangsu, 215006

  • Tianjin Cancer Hospital /ID# 228135

    Tianjin, Tianjin Municipality, 300000

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221

    Wuhan, Hubei, 430022

  • The Affiliated Hospital of Xuzhou Medical College /ID# 228774

    Xuzhou, Jiangsu, 221006

  • Henan Cancer Hospital /ID# 228772

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma

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.

Read more

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.

Keywords
B-Cell Non-Hodgkin Lymphoma, Epcoritamab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, R-CHOP, Rituximab, Lenalidomide, R2, ABBV-GMAB-3013, Cancer, EPCORE
Medical subject headings
Lymphoma, B-Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05201248
Study groupRoleWhat they receive
Cohort 1 Part 1: Epcoritamab MonotherapyExperimentalParticipants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Receives: Drug: Epcoritamab
Cohort 1 Part 2: Epcoritamab ExpansionExperimentalParticipants will receive SC epcoritamab in 28 day cycles.
Receives: Drug: Epcoritamab
Cohort 2: Epcoritamab + RCHOPExperimentalParticipants 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.
Receives: Drug: Epcoritamab; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
Cohort 3: Epcoritamab + R2ExperimentalParticipants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, and oral lenalidomide (R2)] in 28 day cycles.
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)

    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).

    Measured: Up to Approximately 5 Years

  2. Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)

    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.

    Measured: Up to Approximately 5 Years

Secondary outcomes (5)

  1. Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)

    CR is defined as the absence of lymphoma determined by Lugano 2014 criteria as assessed by IRC.

    Measured: Up to Approximately 5 Years

  2. Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)

    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.

    Measured: Up to Approximately 5 Years

  3. Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)

    OS is defined for Cohort 1 epcoritamab monotherapy participants, as the time in months from first dose of epcoritamab to death from any cause.

    Measured: Up to Approximately 5 Years

  4. Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)

    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.

    Measured: Up to Approximately 5 Years

  5. Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)

    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.

    Measured: Up to Approximately 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start10 Mar 2022
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201248
Sponsor's protocol ID
M21-103
Status last verified
Sep 2026
First submitted
18 Jan 2022
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Epcoritamab, Cyclophosphamide and Rituximab in people with B-Cell Non-Hodgkin Lymphoma, run by Genmab at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR) (time frame: Up to Approximately 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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