Hematologic MalignancyPhase 1NCT05860075
Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy
A Phase 1 study testing IMM01 in people with Hematologic Malignancy, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- IMM01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2019to 26 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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 :
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- 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;
- Patients with serious infections within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
- Patients with uncontrolled active infectious lesions requiring oral or intravenous antibiotic therapy;
- Subjects with a history of severe allergy or those who are known to have had severe allergic reactions to large molecular protein preparation/monoclonal antibodies, and any of the components of the investigational drug (greater than grade 3 according to NCI-CTCAE v5.0 classification);
- Patients with a history of alcohol, drug or substance abuse within the last 1 year;
- Patients with a clear previous history of neurological or psychiatric disorders with poor compliance, such as epilepsy, dementia;
- Pregnant and lactating women;
- Subjects with other conditions not suitable for participating in the study at the investigator's discretion
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences and Peking Union Medical College,
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Phase 1 Clinical Study to Evaluate IMM01 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Refractory or Recurrent Hematologic Malignancy
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.
Read the detailed description
IMM01 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle).
The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase.
Once the RP2D is determined, will explore for Classic Hodgkin's lymphoma, B-cell lymphoma,NK/T-cell lymphoma, AML, MDS and MM cohorts.
- Conditions
- Hematologic Malignancy
- Being tested
- IMM01
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM01Drug
Also called IMM01 is a recombinant human signal regulatory protein α (SIRPα) IgG1 fusion protein
IMM01 will be administered once a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: IMM01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs)
Measured: 48 weeks of treatment
Dose-limiting toxicities (DLTs)
Incidence and characteristics of dose-limiting toxicities (DLTs)
Measured: Evaluated during the first treamtment cycle of 28 days
Maximum Tolerated Dose（MTD ）
MTD is the highest dose in patients with DLT incidence <30%.
Measured: 48 weeks of treatment
Secondary outcomes (7)
Anti-drug antibody (ADA)
To evaluate the immunogenicity of IMM01 in patients with refractory or recurrent hematologic malignancy
Measured: 48 weeks of treatment
Overall Rate Response (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Measured: When the last subject enrolled completes approximately 48 weeks of treatment
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have a critical response (CR), partial response (PR) or disease stable (SD)
Measured: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment]
Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)
Measured: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment
Progression-free survival (PFS)
Defined as the duration from the start of treatment until tumor progression or death of any cause
Measured: From start of treatment to treatment termination visit, up to 48 weeks
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration observed in patients with IMM01 dosed
Measured: 48 weeks of treatment
time to maximum concentration (Tmax)
time to maximum concentration observed in patients with IMM01 dosed
Measured: 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start19 Nov 2019
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Why it stopped: No expected efficacy was observed in subsequent extended phase.The company decided to initiatively terminate the development of IMM01 as monotherapy and fully promote clinical development of combination therapy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860075
- Sponsor's protocol ID
- IMM01-I
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate IMM01 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Refractory or Recurrent Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT05860075
- Acronym / sponsor ID
- IMM01-I
- Conditions
- Hematologic Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No expected efficacy was observed in subsequent extended phase.The company decided to initiatively terminate the development of IMM01 as monotherapy and fully promote clinical development of combination therapy.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IMM01 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle).
The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase.
Once the RP2D is determined, will explore for Classic Hodgkin's lymphoma, B-cell lymphoma,NK/T-cell lymphoma, AML, MDS and MM cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| IMM01 in subjects with hematologic malignancy | Experimental | Drug: IMM01The 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
- 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;
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM01Also: IMM01 is a recombinant human signal regulatory protein α (SIRPα) IgG1 fusion proteinIMM01 will be administered once a week for 4 weeks. | Drug | IMM01 in subjects with hematologic malignancy |
Primary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 48 weeks of treatment
Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs)
Dose-limiting toxicities (DLTs)
Time frame: Evaluated during the first treamtment cycle of 28 days
Incidence and characteristics of dose-limiting toxicities (DLTs)
Maximum Tolerated Dose（MTD ）
Time frame: 48 weeks of treatment
MTD is the highest dose in patients with DLT incidence <30%.
7 secondary outcomes
Anti-drug antibody (ADA)
Time frame: 48 weeks of treatment
Overall Rate Response (ORR)
Time frame: When the last subject enrolled completes approximately 48 weeks of treatment
Disease Control Rate (DCR)
Time frame: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment]
Duration of Response (DOR)
Time frame: From start of treatment to the last subject enrolled completes approximately 48 weeks of treatment
Progression-free survival (PFS)
Time frame: From start of treatment to treatment termination visit, up to 48 weeks
Maximum Plasma Concentration (Cmax)
Time frame: 48 weeks of treatment
time to maximum concentration (Tmax)
Time frame: 48 weeks of treatment
Results and safety
The study was stopped early (reason given: No expected efficacy was observed in subsequent extended phase.The company decided to initiatively terminate the development of IMM01 as monotherapy and fully promote clinical development of combination therapy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMM01 in people with Hematologic Malignancy, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No expected efficacy was observed in subsequent extended phase.The company decided to initiatively terminate the development of IMM01 as monotherapy and fully promote clinical development of combination therapy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 48 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.