Recombinant Humanized Anti-CD47/PD-1 Bifunctional Antibody HX009 in Patients With Relapsed/Refractory Lymphoma

NCT05189093 | Completed Phase 1 DMC

• 1 other identifier: HX009-II-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, open, single-arm phase I/II clinical study to evaluate the recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in Chinese patients with relapsed/refractory lymphoma .

Conditions

Relapsed/Refractory Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR) of patients with solid tumors treated with HX009 per Investigator Assessment

  Objective response rate (ORR) assessed according to the evaluation criteria of each tumor type

  Tumor assessment every 6 weeks (±7 days)，up to 1 year

Secondary Outcomes (21)

• 6 months and 12 months progression-free survival (PFS )

  Approximately 1 year

• Complete Remission Rate (CRR)

  Approximately 1 year

• Duration of Remission (DOR)

  Tumor assessment every 6 weeks (±7 days),up to 1year

• Disease Control Rate (DCR)

  Tumor assessment every 6 weeks (±7 days),up to 1 year

• Incidence and severity of AE and SAE, laboratory tests and vital signs（Including ：heart rate, blood pressure, respiration,temperature.）;

  All AEs up to 28 days after the last dose of study drug,Or other tumor treatment programs have been started (the earlier date shall prevail); irAE should be followed up to 90 days after the last dose, or other tumor treatment programs have been started

Study Arms (1)

phase I dose escalation part,Phase II efficacy exploratory part and the efficacy confirmation part

EXPERIMENTAL

Phase Ib/II efficacy exploration and confirmation phase: Four cohorts will be conducted in parallel to initially evaluate the recombinant humanized anti-CD47/PD-1 bifunctional anti HX009 injection. The four cohorts in the efficacy exploration phase are: Cohort 1: Relapsed/refractory diffuse large B-cell lymphoma; Cohort 2: relapsed/refractory peripheral T-cell lymphoma (except angioimmunoblastic T-cell lymphoma). (except angioimmunoblastic T-cell lymphoma); Cohort 3: relapsed/refractory follicular lymphoma and relapsed/refractory marginal zone lymphoma; Cohort 4: relapsed/refractory EBV-positive non-Hodgkin's lymphoma.

Drug: Recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection

Interventions

Recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection DRUG

There will be a total of 4 cohorts, each cohort will explore 1-2 dose levels, i.e. 10 mg/kg and 15 mg/kg, with an expected enrollment of 40-80 cases. The 10 mg/kg dose level will be enrolled first, the After discussion between the sponsor and the DSC, the 15 mg/kg dose level will be enrolled if necessary. Based on the DMC analysis, the no-trend cohort will be enrolled in a maximum of 10 cases (with the possibility of stopping enrollment halfway through).

phase I dose escalation part,Phase II efficacy exploratory part and the efficacy confirmation part

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participating in a clinical research study, being fully aware of and informed about the study and signing the Informed Consent Form (ICF).
• Willing to follow and capable of completing all study procedures;
• Male and Female. Age 18-65 years (including borderline values) in the dose-escalation phase; age 18-70 years (including borderline values) in the efficacy exploration and confirmation phase;
• lymphoma diagnosed according to the 5th edition of the WHO Classification Criteria for 2022 and meeting the following definition of relapsed or refractory.
• The Phase Ib efficacy exploration phase will carry out cohort expansion according to the following tumors:
• Patients with relapsed/refractory diffuse large B-cell lymphoma (including transformed DLBCL): need to have received systemic therapy with at least two standard regimens;
• Relapsed/refractory peripheral T-cell lymphoma (except angioimmunoblastic T-cell lymphoma): Patients with relapsed/refractory peripheral T-cell lymphoma (except angioimmunoblastic T-cell lymphoma);
• Relapsed/refractory follicular lymphoma and relapsed/refractory marginal zone lymphoma: at least two standard regimens of systemic therapy are required.
• Relapsed/refractory EBV-positive non-Hodgkin's lymphoma: at least one systemic regimen is required.
• an Eastern Cooperative Oncology Group (ECOG) Physical Strength Score of 0 to 2 within 14 days prior to first dose;
• expected survival ≥ 3 months;
• good major organ function, i.e., meeting the following criteria:
• Blood system
• Absolute neutrophil count (ANC) ≥1.5 × 10/L; with bone marrow invasion, ANC ≥1.0 × 10/L;
• Platelets ≥75 × 10/L (without bone marrow invasion) and platelets ≥50.0 × 10/L (with bone marrow or spleen invasion);

You may not qualify if:

• Prior history of a malignancy other than skin cancer or carcinoma in situ that is not melanoma (e.g., cervical cancer, bladder cancer, breast cancer, etc.) unless disease-free status has been achieved for 3 years;
• failure to recover from adverse effects of prior therapy to a CTCAE 5.0 grade score of ≤1, except for residual 3. active gastrointestinal ulcers
• active peptic ulcer, incomplete intestinal obstruction, active gastrointestinal bleeding and perforation;
• known history of hereditary or acquired hemolytic or bleeding disorders;
• subjects with primary or secondary central nervous system (CNS) lymphoma;
• patients who have received prior targeted therapy with CD47 (including monoclonal antibodies, bispecific antibodies, etc.);
• patients who have received a blood transfusion or hematopoietic stimulating factor therapy, such as colony-stimulating factor, erythropoietin, erythropoietin, or other stimulating factors within 2 weeks prior to the start of treatment Erythropoietin, thrombopoietin, thrombopoietin, etc;
• Subjects with an active, or history of, autoimmune disease that is likely to recur or is being treated (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (e.g., who have received organ transplants and need to be treated for immune-suppressant therapy); however, enrollment is permitted in subjects who have :
• Type 1 diabetes mellitus that has stabilized with the use of fixed-dose insulin;
• Autoimmune hypothyroidism and adrenal insufficiency requiring only hormone replacement therapy Adenosine insufficiency;
• Skin diseases that do not require systemic therapy. For example, eczema, a rash that accounts for less than 10% of the body surface, without ophthalmologic symptoms (primarily dry eyes, blepharitis, conjunctivitis, lid adhesions Psoriasis without ophthalmologic symptoms (mainly dry eye, conjunctivitis, lid adhesions, keratitis, and uveitis);
• major surgery during the Screening Period 28 days prior to the first dose or minor surgery within 2 weeks (except diagnostic surgery), and any elective major surgery during the planned study period;
• Subjects requiring systemic corticosteroids (dose equivalent to \>10 mg prednisone/day) or other immunosuppressive medications within 14 days prior to the first dose or during the study period; the following conditions to \>10 mg prednisone/day) or other immunosuppressive medications within 14 days prior to the first dose or during the study period; the following were Enrollment is permitted:
• Subjects on topical topical or inhaled glucocorticoids;
• Short-term (≤7 days) use of glucocorticoids for prophylaxis or treatment of non-autoimmune allergic diseases. allergic diseases;

Sponsors & Collaborators

• Hangzhou Hanx Biopharmaceuticals, Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciense

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuankai Shi

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

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: December 8, 2021
• First Posted: January 12, 2022
• Study Start: December 31, 2021
• Primary Completion: June 25, 2025
• Study Completion: December 31, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)