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

NCT ID: NCT05201248

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2025-04-30

Brief 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, 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.

Conditions

B-Cell Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 Part 1: Epcoritamab Monotherapy

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

Group Type: EXPERIMENTAL

Epcoritamab

Intervention Type: DRUG

Subcutaneous Injection (SC)

Cohort 1 Part 2: Epcoritamab Expansion

Participants will receive SC epcoritamab in 28 day cycles.

Group Type: EXPERIMENTAL

Epcoritamab

Intervention Type: DRUG

Subcutaneous Injection (SC)

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.

Group Type: EXPERIMENTAL

Epcoritamab

Intervention Type: DRUG

Subcutaneous Injection (SC)

Cyclophosphamide

Intervention Type: DRUG

IV Injection

Rituximab

Intervention Type: DRUG

Intravenous (IV) Infusion

Doxorubicin

Intervention Type: DRUG

IV Infusion

Vincristine

Intervention Type: DRUG

IV Infusion

Prednisone

Intervention Type: DRUG

Oral; Tablet

Cohort 3: Epcoritamab + R2

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

Group Type: EXPERIMENTAL

Epcoritamab

Intervention Type: DRUG

Subcutaneous Injection (SC)

Rituximab

Intervention Type: DRUG

Intravenous (IV) Infusion

Lenalidomide

Intervention Type: DRUG

Oral; Capsule

Interventions

Epcoritamab

Subcutaneous Injection (SC)

Intervention Type: DRUG

Cyclophosphamide

IV Injection

Intervention Type: DRUG

Rituximab

Intravenous (IV) Infusion

Intervention Type: DRUG

Doxorubicin

IV Infusion

Intervention Type: DRUG

Vincristine

IV Infusion

Intervention Type: DRUG

Prednisone

Oral; Tablet

Intervention Type: DRUG

Lenalidomide

Oral; Capsule

Intervention Type: DRUG

Other Intervention Names

ABBV-GMAB-3013

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Genmab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Beijing, Beijing Municipality, China

Peking University Third Hospital /ID# 228138

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital /ID# 231890

Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center /ID# 228033

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital /ID# 228028

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University /ID# 227916

Guangzhou, Guangdong, China

Henan Cancer Hospital /ID# 228772

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital /ID# 231859

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University /ID# 228024

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical College /ID# 228774

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University /ID# 228771

Nanchang, Jiangxi, China

Jiangxi Provincial Cancer Hospital /ID# 231944

Nanchang, Jiangxi, China

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

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University /ID# 231434

Chengdu, Sichuan, China

Tianjin Cancer Hospital /ID# 228135

Tianjin, Tianjin Municipality, China

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

Hangzhou, Zhejiang, China

Zhejiang Cancer hospital /ID# 228776

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

M21-103

Identifier Type: -

Identifier Source: org_study_id