A Study of ATG-010 in Combination With Lenalidomide and Rituximab (R2) in Adults With DLBCL and iNHL

NCT05265975 | Terminated Phase 1

• 1 other identifier: ATG-010-B-NHL-002
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

Brief Summary

A Single-arm, Phase Ⅰ/Ⅱ Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ATG-010 in Combination with Lenalidomide and Rituximab (R2) in Adult Patients with Relapsed/Refractory DLBCL and iNHL Who are Ineligible for High-dose Chemotherapy (HDC) or Autologous Stem Cell Transplant (A SCT).

Conditions

Diffuse Large B-cell Lymphoma; Indolent Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• DLT

  The occurrence of severe toxicities during the first cycle of systemic cancer therapy

  28 days after administration

• AE

  Any adverse medical event that occurs after a patient or clinical trial subject receives a drug product, but is not necessarily related to the treatment.

  28 days after administration

Secondary Outcomes (4)

• ORR

  One year after last patient first dose

• PFS

  One year after last patient first dose

• DOR

  One year after last patient first dose

• OS

  One year after last patient first dose

Study Arms (1)

ATG-010

EXPERIMENTAL

Enrolled patients will be treated with dosage groups. Dosage group 1:40mg/time, dosage group 2:60mg/time, dosage group 3:80mg/time; The treatment period was 28 days. The drug was administered on day 1,8 and 15 of each cycle

Drug: ATG-010; Drug: Lenalidomide; Drug: Rituximab

Interventions

ATG-010 DRUG

Tablets,20mg, once a week: dosage group 1:40mg/time, dosage group 2:60mg/time, dosage group 3:80mg/time The treatment period was 28 days. The drug was administered on day 1,8 and 15 of each cycle

Also known as: Selinexor

ATG-010

Lenalidomide DRUG

Oral administration,QD, Days 1-21 of each cycle

ATG-010

Rituximab DRUG

Intravenous injection Days 1 of each cycle, Cycles 1-6

ATG-010

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Pathologically confirmed DLBCL (including de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma \[e.g., follicular lymphoma\]) or B-cell iNHL with histological subtype limited to FL Grade 1, Grade 2, or Grade 3a or nodal or extranodal marginal zone lymphoma (MZL), based on criteria established by the World Health Organization (WHO) 2016 classification.
• Received at least 1 line of systemic therapy for the treatment of B-NHL.
• Have evidence of relapse or refractory disease.
• At least one bi-dimensionally measurable lesion per the Lugano 2014 Criteria (Cheson, 2014; Appendix 4).
• Adequate bone marrow function at screening, defined as:
• (1) absolute neutrophil count (ANC) ≥1.0 × 109/L (without hematopoietic stimulators such as granulocyte or granulocyte-macrophage colony stimulating factor within 7 days prior to testing); (2) Platelet count ≥75 × 109/L; or ≥50 × 109/L when lymphoma infiltrates bone marrow (without platelet transfusion or TPO, IL-11 and other hematopoietic stimulating factors administration within 7 days prior to testing); (3) Hemoglobin ≥80 g/L (without red blood cell transfusion or hematopoietic stimulating factor such as TPO administration within 14 days prior to testing).
• \. Adequate liver and kidney function, defined as:
• Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN);
• Serum total bilirubin ≤1.5 × ULN, or ≤3 ULN if have Gilbert syndrome;
• Calculated creatinine clearance (CrCl) ≥60 mL/min for Dose Escalation Phase, and ≥30 mL/min for Dose Expansion Phase, based on Cockcroft-Gault formula.
• \. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 9. Agree to effective contraception during the study and within 12 months after the last dose of study treatment.

You may not qualify if:

• DLBCL with MALT lymphoma; composite lymphoma (Hodgkin's lymphoma+NHL); primary mediastinal (thymic) large B-cell lymphoma; Grade 3b follicular lymphoma.
• Dose Escalation Phase: Subjects with known central nervous system involvement. Dose Expansion Phanse: Subjects with advanced lymphoma of the central nervous system involvement at screening, however, subjects have stable central nervous system lymphoma (in the case of no intracranial pressure or other conditions need medical intervention) or do not occur disease progression as assessed by neurological symptoms, signs, and radiography within 28 days prior to C1D1, will be considered eligible.
• Previous treatment with ATG-010 (selinexor) or other XPO1 inhibitors, or prior exposure to lenalidomide within 3 months before C1D1.
• Contraindication to any drug in the combination therapy of SR2.
• Use of any standard or experimental anti B-NHL therapy \<21 days prior to C1D1, including chemotherapy, immunotherapy, radio-immunotherapy, nonpalliative radiation, or any other anticancer therapy.
• Major surgery, or live vaccines received \<28 days prior to C1D1.
• ASCT \<6 months or CAR-T cell infusion \<6 months prior to the screening.
• History of allogeneic hematopoietic stem cell transplant.
• Have active hepatitis B virus (HBV), hepatitis C virus (HCV) infections at screening.
• Known serum HIV antibody positive or history of active HIV infection.
• Active infection requiring intravenous antibiotics, antivirals, or antifungals treatment within 14 days prior to C1D1; however, prophylactic use of these agents is acceptable (including intravenous medication).
• Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) within the 2 years prior to C1D1.
• Ischemic or hemorrhagic cerebrovascular disease, or gastrointestinal hemorrhage ≥Grade 3 (CTCAE, v5.0) within 6 months prior to screening.
• History of deep vein thrombosis or pulmonary embolism within 12 months prior to screening.
• Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal disease or dysfunction that could interfere with absorption of study treatment.

Sponsors & Collaborators

• Antengene Corporation: lead

Study Sites (6)

The Second Affiliated Hospital of PLA Army Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

The first Affiliated Hospital of China medical University

Shenyang, Liaoning, 110001, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

selinexor; Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 4, 2022
• Study Start: April 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 9, 2025

Record last verified: 2025-03

Locations

CN (6)