Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy

NCT05860075 | Terminated Phase 1 DMC

• 1 other identifier: IMM01-I
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM01 in subjects with refractory or recurrent hematologic malignancy.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs)

  48 weeks of treatment

• Dose-limiting toxicities (DLTs)

  Incidence and characteristics of dose-limiting toxicities (DLTs)

  Evaluated during the first treamtment cycle of 28 days

• Maximum Tolerated Dose（MTD ）

  MTD is the highest dose in patients with DLT incidence \<30%.

  48 weeks of treatment

Secondary Outcomes (7)

• Anti-drug antibody (ADA)

  48 weeks of treatment

• Overall Rate Response (ORR)

  When the last subject enrolled completes approximately 48 weeks of treatment

• Disease Control Rate (DCR)

  From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment]

• Duration of Response (DOR)

  From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment

• Progression-free survival (PFS)

  From start of treatment to treatment termination visit, up to 48 weeks

Study Arms (1)

IMM01 in subjects with hematologic malignancy

EXPERIMENTAL

The escalation dosing were 3µg/kg, 10µg/kg, 50µg/kg, 150µg/kg, 500µg/kg, 1.0mg/kg, 1.5mg/kg and 2.0mg/kg. The extend cohorts were Hodgkin's lymphoma, B-cell lymphoma,NK/T-cell lymphoma,AML,MDS and MM cohorts

Drug: IMM01

Interventions

IMM01 DRUG

IMM01 will be administered once a week for 4 weeks.

Also known as: IMM01 is a recombinant human signal regulatory protein α (SIRPα) IgG1 fusion protein

IMM01 in subjects with hematologic malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are voluntary to sign an informed consent form, agree to follow and have the ability to complete all trial procedures with knowledge of the study;
• Male or female, aged ≥18 and ≤ 75 years;
• Patients with refractory or recurrent lymphoma diagnosed according to the 2016 WHO classification criteria; the relapsed, refractory lymphoma is defined as follows: Relapse is considered to occur when a new lesion appears at the primary site or elsewhere when response has been achieved with at least one current standard or commonly used regimen;
• Lymphoma is considered refractory if one of the following conditions is met:
• Less than 50% tumor shrinkage or disease progression occurs after ≥4 cycles of treatment with current standard or commonly used regimens; Patients who have achieved partial or complete response by current standard or commonly used regimens and relapsed within six months after termination of treatment;
• There is at least one measurable or evaluable tumor lesion (preferentially enrolled the measurable lesions), measurable lesions: lymph nodes with longest diameterof ≥15 mm, metastatic lesions (≥10 mm) at other sites; lesions previously treated with local therapy such as radiotherapy are considered measurable lesions if disease progression has been demonstrated;
• Patients with a performance status score of 0\~2 according to the Eastern Cooperative Oncology Group (ECOG) scale;
• Expected life expectancy of at least 3 months;
• If prior anti-tumor therapy has been received , the interval to the first dose in this study should meet the following conditions: Those who have used chemotherapy drugs previously need to discontinue for more than 4 weeks.Those with a history of surgery, targeted therapy (including anti CD20 monoclonal antibodies such as rituximab; CD30 monoclonal antibodies such as Brentuximab Vedotin), therapy with anti tumor indications, and palliative radiotherapy should discontinue the treatment for more than 4 weeks;Those with prior CAR-T cell therapy or PD-1/PD-L1 monoclonal antibody therapy need to discontinue for at least 8 weeks;And they have recovered from toxic reactions to previous treatment to grade ≤ 1 identified by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (NCI CTCAE v5.0) (except for residual alopecia).
• Suitable organs and hematopoietic functions are available. Absolute neutrophil count (ANC) ≥1.0×109/L (no use of short-acting leucopenia drugs within 1 week or no use of long-acting leucopenia drugs within 3 weeks). Patients have not received platelet transfusion within 1 week; platelets
• ≥75×109/L (without bone marrow infiltration)/ ≥50.0×109/L (with bone marrow infiltration).
• Patients have not received red blood cell transfusion within 2 weeks; hemoglobin ≥90 g/L (without bone marrow infiltration)/ ≥70 g/L (with bone marrow infiltration).
• Serum creatinine ≤ 1.5 times the upper limit of normal (ULN). AST and ALT ≤ 2.0 times ULN; Serum total bilirubin (TBIL) ≤ 2 times ULN; International normalized ratio (INR) ≤ 2 times ULN, or activated partial thromboplastin time (APPT) ≤ 1.5 times ULN;
• Male subjects and female subjects of childbearing age should agree to take effective contraceptive measures from the time they sign the informed consent until 6 months after the last dos

You may not qualify if:

• Patients with any of the following cannot be enrolled: previous allogeneic hematopoietic stem cell transplantation and other organ transplantation; a history of autologous hematopoietic stem cell transplantation for not more than six months.
• Patients have participated in clinical trials of other drugs or medical devices within 4 weeks prior to the first dose of this study;
• Presence of central nervous system metastatic lesion;
• Patients with previous or current other malignancies (except cured stage IB or lower grade cervical cancer, non-invasive basal cell or squamous cell skin cancer; except other malignancies that have achieved complete response (CR) for \>5 years and have not been treated with antineoplastic therapy for 5 years);
• Subjects with active autoimmune disease, or a history of autoimmune disease with a risk of relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc., see Appendix 6), or patients at high risk (e.g., those requiring immunosuppressive therapy after undergoing organ transplantation).
• However, subjects with the following diseases are allowed to enroll :
• Those with autoimmune hypothyroidism who require hormone replacement therapy only; Those with skin conditions (such as eczema, rash covering less than 10% of the body's surface) that do not require systemic treatment;
• Patients who have undergone major surgery within 28 d prior to enrollment or who are expected to have major surgery during this study period including the 21 d screening period.
• Subjects requiring systemic corticosteroids (at a dose equivalent to \>10 mg prednisone/d) or other immunosuppressive drugs within 14 d prior to enrollment or during the study period; the the patients meet the following conditions are allowed for enrollment: Subjects are allowed to use topical or inhaled glucocorticoids; Short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases is allowed;
• Patients with a history of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment or with evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity; partial prothrombin time (APTT) or prothrombin time (PT) \> 1.2 × ULN; oral warfarin with an international normalized ratio (INR) \> 1.2 × ULN
• Patients with acute lung disease, interstitial lung disease or pneumonia (except for local interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, acute lung disease, etc.;
• Systemic diseases that have not been stably controlled after treatment, such as diabetes, severe organic cardiovascular disease, cardiac insufficiency, hypertension, heart block of degree II or higher, myocardial infarction within 6 months and cerebral infarction within 6 months, etc;
• Patients with positive HIV test;
• Patients with active tuberculosis disease at screening;
• Patients with HBsAg (+); with HBsAg (-) but HBV-DNA quantification exceeding the upper limit of the normal; Patients with HCV-Ab (+); with HCV-Ab (-) but HCV-RNA quantification exceeding the upper limit of the normal;

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

Study Sites (1)

Chinese Academy of Medical Sciences and Peking Union Medical College,

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

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

Model Details: This is an open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM01 in subjects with relapsed or refractory lymphoma.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 16, 2023
• Study Start: November 19, 2019
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-04

Locations

CN (1)