IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Advanced Primary Liver Cancer

NCT05411757 | Unknown Early Phase 1

• 1 other identifier: IBR900-T02
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, nonrandomized investigator-initiated clinical trial to evaluate the safety, tolerability, and efficacy of IBR900 cell injection in combination with Lenvatinib or bevacizumab in subjects with advanced primary liver cancer.

Conditions

Advanced Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  The incidence and severity of adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and the correlation between adverse events and IBR900 cell injection.

  From day 1 to day 90 after the last infusion

Secondary Outcomes (5)

• Objective response rate (ORR)

  Up to 1 year after infusion

• Progression-free survival (PFS)

  Up to 1 year after infusion

• Overall survival (OS)

  Up to 5 year after infusion

• Disease control rate (DCR)

  Up to 1 year after infusion

• Best of response (BOR)

  Up to 1 year after infusion

Other Outcomes (2)

• Cytokine release

  Up to 1 year after infusion

• Lymphocyte subtype

  Up to 1 year after infusion

Study Arms (1)

IBR900 cell injection

EXPERIMENTAL

IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab

Combination Product: IBR900 combined with Lenvatinib; Combination Product: IBR900 combined with Bevacizumab

Interventions

IBR900 combined with Lenvatinib COMBINATION_PRODUCT

IBR900 cell injection: 4.0×10\^9 cells, D1,D3 of each cycle. Lenvatinib: body weight ≥ 60kg, 12mg/qd; body weight \< 60kg, 8mg/qd; administered continuously from D5 of the first cycle

IBR900 cell injection

IBR900 combined with Bevacizumab COMBINATION_PRODUCT

IBR900 cell injection: 4.0×10\^9 cells, D1,D3 of each cycle. Bevacizumab:15mg/kg, D1 of each cycle.

IBR900 cell injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age≥18 and ≤75 years old.
• Subjects with stage IIb, # or IV unresectable / advanced primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma or mixed hepatocellular cholangiocarcinoma diagnosed in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer of CSCO(2020 Edition).
• Having ≥ 1 measurable lesion in accordance with the modified Response Evaluation Criteria in Solid Tumors (mRECIST) (lesions located in the field of previous radiation therapy cannot be used as target lesions unless there is imaging evidence that the lesion has progressed or persisted three months after radiation therapy).
• Have a performance status of 0 or 2 on the ECOG Performance Score, life expectancy ≥12 weeks.
• Male and female subjects of childbearing age and their partners must agree to take effective birth controls (hormone, barrier method or abstinence, etc.) from signing the ICF to 6 months after the last administration.
• Subjects should voluntarily participate in this clinical study, are fully aware of the study, have signed the Informed Consent Forms, and are willing to follow and able to complete all trial procedures.

You may not qualify if:

• Received systemic anti-tumor therapy within 4 weeks prior to the first administration, including chemotherapy, immunotherapy, radical radiotherapy, etc.; received palliative radiotherapy within 2 weeks prior to the first administration; or the adverse events caused by previous anti-tumor therapy have not recovered to ≤Grade 1 (except for alopecia).
• Have known central nervous system metastases with clinical symptoms.
• Received any adoptive cellular immunotherapy within 6 months prior to the first administration.
• Have undergone major organ surgery (excluding needle biopsy or surgery related to this indication) within 4 weeks prior to their first administration of the study drug, or required elective surgery during the study period.
• Have received or expected to receive glucocorticoids (prednisone \>10 mg daily or equivalents) or other immunosuppressive medications within 14 days prior to the first administration. Note: For subjects without active autoimmune disorder, inhaled or topical steroid hormone or equivalent dose of prednisone ≤ 10 mg/day is allowed, and glucocorticoid is allowed for short-term (≤ 7 days) preventive treatment (e.g. contrast media allergy) or for the treatment of non-autoimmune disorder (e.g. delayed type hypersensitivity to contact allergens).
• Received live or attenuated vaccine within 4 weeks prior to the first administration or plan to receive live or attenuated vaccine during the study period.
• Patients with severe infections that cannot be controlled.
• Patients with a known history of human immunodeficiency virus (HIV) active infection.
• Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes well controlled with hormone replacement therapy, hypothyroidism, skin conditions not requiring systemic therapy (such as vitiligo), and other conditions that are well controlled and that are less likely to relapse as by the investigator (such as resolved childhood asthma).
• Organ function during screening should meet the following criteria:
• Absolute neutrophil count (ANC)\<1.5×10\^9/L, platelet (PLT)\<75×10\^9/L, hemoglobin (Hb)\<80g/L, (blood transfusion, platelet and colony stimulating factor therapy are not allowed within 2 weeks before the test);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\>5 times the upper limit of normal (ULN), and total serum bilirubin\>2.5 times the upper limit of normal (ULN);
• Creatinine(Cr)\>1.5×ULN, and creatinine clearance rate(Ccr) ≤ 60ml/min (estimated according to Cockcroft-Gault formula). Note: Ccr to be calculated only when Cr \>1.5×ULN;
• International normalized ratio (INR) ≤ 2.0×ULN, activated partial thrombin time (APTT) \>1.5×ULN.
• Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:

Sponsors & Collaborators

• Shandong Public Health Clinical Center: lead
• Imbioray (Hangzhou) Biomedicine Co., Ltd.: collaborator

MeSH Terms

Interventions

lenvatinib; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jingbo Wang

  Head of the department of Biology and Cell therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodi Li

CONTACT

+8617860107786; sdgwzx2022@163.com

Study Design

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

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 9, 2022
• Study Start: June 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 9, 2022

Record last verified: 2022-06