HematomaPhase 1/2NCT05210868
A Phase I/II Study of CM355 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)
A Phase 1/2 study testing CM355 in people with Hematoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
A Phase I/II Open-Label, Single-Arm, Multicenter Clinical Study of CM355 in Patients With R/R B-NHL Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematoma
- What is being tested?
- CM355
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG, see Appendix 3) PS score of 0-1.
- Histopathologically confirmed relapsed or refractory B-cell NHL has been confirmed or anticipated to express CD20 in lymphoma lesions.
- According to Lugano criteria, imaging evaluation shows at least one bidimensionally measurable lesion.
- The level of organ function of patients must In line with the testing standard of the clinical trial center prior to the first dose of the investigational drug
- Expected survival ≥ 3 months.
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- All toxicities caused by prior anticancer therapy must have recovered to grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.
- Female patients with childbearing potential should have a negative blood pregnancy test result within 7 days prior to the first dose.
- Female patients with childbearing potential or male patients and their partners must agree to take effective contraceptive measures from the signing of the ICF to at least 6 months after the last dose of investigational drug.
- Female patients cannot breastfeed or plan to become pregnant during the study until at least 6 months after the last dose of investigational drug.
- The patient voluntarily joined the study and signed the ICF.
Who cannot join
- Active or past central nervous system (CNS) lymphoma.
- Other active malignancies occurring within 5 years prior to the first dose of investigational drug, with the exception of radically treated local curable cancers.
- The patient has a disease or medical history that needs to be excluded as specified in the Clinical Trial Protocol.
- Any active infection requiring systemic therapy via intravenous infusion within 14 days prior to the first dose of investigational drug.
- According to the trial scheme, patients infected with hepatitis B virus, hepatitis C virus, HIV, EBV, CMV, syphilis, or patients with active pulmonary tuberculosis or history of pulmonary tuberculosis infection are not suitable to participate in the study.
- Any severe or uncontrolled systemic disease.
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- History of severe allergic reactions (CTCAE v5.0 classification is greater than 3 grades) to humanized monoclonal antibodies, or known hypersensitivity to any component of CM355.
- Any mental or cognitive disorder that may limit the patient's understanding and execution of the ICF and compliance with the study.
- Medication history and surgical history:
- Having received allogeneic hematopoietic stem cell transplantation or received auto-HSCT within 100 days prior to the first dose.
- Active bleeding within 2 months prior to screening, or receiving anticoagulants, or other bleeding symptoms requiring medical intervention.
- Having undergone major surgery within 28 days prior to the first dose, or minor surgery within 2 weeks prior to the first dose; invasive examinations for the purpose of diagnosis are not considered as surgery; except for the insertion of vascular access device.
- Patients who experienced grade ≥ 3, severe or life-threatening immune-related adverse events or grade 1-2 immune-related adverse events that did not return to baseline levels after treatment discontinuation in a previous immunotherapy.
- Patients who have received any other investigational anti-cancer drug therapy within 28 days prior to the first dose.
- Inoculation of live attenuated vaccines within 28 days prior to the first dose, or anticipation that live attenuated vaccines will be required during the study.
- Patients who have received any drugs therapy that need to be excluded from the Clinical Trial Protocol within a certain period of time for the first administration.
- Prior participation in other clinical trials within 28 days prior to the first dose of the investigational drug, or planning to participate in this study and other clinical trials at the same time.
- Known alcoholism or drug abuse history.
- Other conditions determined by the investigator that render patients unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Open-Label, Single-Arm, Multicenter Clinical Study of CM355 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)
A Phase I/II Open-Label, Single-Arm, Multicenter Clinical Study of CM355 in Patients With R/R B-NHL
Read the detailed description
This is a phase I/II open-label, single-arm, multicenter study in China to evaluate the safety, tolerability, and efficacy of CM355 in patients with R/R B-NHL. In the study, patients will not be screened for CD20 expression, but they must have a diagnosis of B-NHL that is expected to express CD20. After enrollment, tumor samples will be collected for retrospective analysis of CD20 expression
- Conditions
- Hematoma
- Being tested
- CM355
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM355Drug
- Dose Escalation Phase CM355 will be taken by patients and will be treated follow the "3+3" dose escalation scheme
- Expansion Phase CM355 will be taken by patients and will assess the efficacy of CM355 in patients with specific histopathological Non-Hodgkin's Lymphoma, and the safety of drug
| Study group | Role | What they receive |
|---|---|---|
| CM355 | Experimental | 1. Dose Escalation Phase CM355
2. Dose Expansion Phase CM355 Receives: Drug: CM355 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Incidence, nature, and severity of dose-limiting toxicities.
Measured: Up to 2 year
Recommended phase II dose (RP2D) and/or (maximum tolerated dose) MTD
To determine the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of CM355 in patients with R/R B-NHL.
Measured: Up to 2 year
Objective response rate（ORR）
Objective response rate (ORR) as assessed by independent review committee (IRC)
Measured: through study completion，an average of 5 year
The safety and tolerability of CM355
Incidence, nature, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0.
Measured: through study completion，an average of 5 year
Secondary outcomes (11)
Peak Plasma Concentration (Cmax)
Dose Escalation peak plasma concentration (ng/mL)
Measured: Every cycle (21 days), until the end of treatment
Area under the plasma concentration versus time curve (AUC)
Dose Escalation AUC（μg·h/mL）
Measured: Every cycle (21 days), until the end of treatment
Peak time
Time of maximum observed plasma concentration (Tmax)
Measured: Every cycle (21 days), until the end of treatment
T1/2
Terminal half-life of CM355
Measured: Every cycle (21 days), until the end of treatment
Clearanc (CL)
Total body clearance of the drug from plasma (CL) of CM355
Measured: Every cycle (21 days), until the end of treatment
Anti-CM355 antibodies (ADAs)
Incidence of anti-CM355 antibodies (ADAs) and their correlation with clinical outcomes.
Measured: Every cycle (21 days), until the end of treatment
Objective response rate (ORR)
Objective response rate (ORR) as assessed by investigators
Measured: through study completion，an average of 5 year
Complete response rate (CRR)
Complete response rate (CRR) as assessed by investigators or independent review committee (IRC)
Measured: through study completion，an average of 5 year
Duration of response (DOR)
Duration of response (DOR) as assessed by investigators or Independent review committee (IRC)
Measured: through study completion，an average of 5 year
Progression-Free-Survival (PFS)
Progression-Free-Survival (PFS) as assessed by investigators or independent review committee (IRC)
Measured: through study completion，an average of 5 year
overall survival (OS)
overall survival (OS) as assessed by investigators or independent review committee (IRC)
Measured: through study completion，an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start16 Nov 2021
- Primary completion28 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematomaStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuqin Song, M.D., Principal investigator, Beijing university cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210868
- Sponsor's protocol ID
- CM355-001
- Status last verified
- Nov 2021
- First submitted
- 9 Dec 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label, Single-Arm, Multicenter Clinical Study of CM355 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT05210868
- Acronym / sponsor ID
- CM355-001
- Conditions
- Hematoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2022 (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.
A Phase I/II Open-Label, Single-Arm, Multicenter Clinical Study of CM355 in Patients With R/R B-NHL
Detailed description
This is a phase I/II open-label, single-arm, multicenter study in China to evaluate the safety, tolerability, and efficacy of CM355 in patients with R/R B-NHL. In the study, patients will not be screened for CD20 expression, but they must have a diagnosis of B-NHL that is expected to express CD20. After enrollment, tumor samples will be collected for retrospective analysis of CD20 expression
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM355 | Experimental | Drug: CM3551. Dose Escalation Phase CM355 2. Dose Expansion Phase CM355 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG, see Appendix 3) PS score of 0-1.
- Histopathologically confirmed relapsed or refractory B-cell NHL has been confirmed or anticipated to express CD20 in lymphoma lesions.
- According to Lugano criteria, imaging evaluation shows at least one bidimensionally measurable lesion.
- The level of organ function of patients must In line with the testing standard of the clinical trial center prior to the first dose of the investigational drug
Key exclusion criteria (19 listed)
- Active or past central nervous system (CNS) lymphoma.
- Other active malignancies occurring within 5 years prior to the first dose of investigational drug, with the exception of radically treated local curable cancers.
- The patient has a disease or medical history that needs to be excluded as specified in the Clinical Trial Protocol.
- Any active infection requiring systemic therapy via intravenous infusion within 14 days prior to the first dose of investigational drug.
- According to the trial scheme, patients infected with hepatitis B virus, hepatitis C virus, HIV, EBV, CMV, syphilis, or patients with active pulmonary tuberculosis or history of pulmonary tuberculosis infection are not suitable to participate in the study.
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 |
|---|---|---|
| CM3551. Dose Escalation Phase CM355 will be taken by patients and will be treated follow the "3+3" dose escalation scheme 2. Expansion Phase CM355 will be taken by patients and will assess the efficacy of CM355 in patients with specific histopathological Non-Hodgkin's Lymphoma, and the safety of drug | Drug | CM355 |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: Up to 2 year
Incidence, nature, and severity of dose-limiting toxicities.
Recommended phase II dose (RP2D) and/or (maximum tolerated dose) MTD
Time frame: Up to 2 year
To determine the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of CM355 in patients with R/R B-NHL.
Objective response rate（ORR）
Time frame: through study completion，an average of 5 year
Objective response rate (ORR) as assessed by independent review committee (IRC)
The safety and tolerability of CM355
Time frame: through study completion，an average of 5 year
Incidence, nature, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0.
11 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Every cycle (21 days), until the end of treatment
Area under the plasma concentration versus time curve (AUC)
Time frame: Every cycle (21 days), until the end of treatment
Peak time
Time frame: Every cycle (21 days), until the end of treatment
T1/2
Time frame: Every cycle (21 days), until the end of treatment
Clearanc (CL)
Time frame: Every cycle (21 days), until the end of treatment
Anti-CM355 antibodies (ADAs)
Time frame: Every cycle (21 days), until the end of treatment
Objective response rate (ORR)
Time frame: through study completion，an average of 5 year
Complete response rate (CRR)
Time frame: through study completion，an average of 5 year
Duration of response (DOR)
Time frame: through study completion，an average of 5 year
Progression-Free-Survival (PFS)
Time frame: through study completion，an average of 5 year
overall survival (OS)
Time frame: through study completion，an average of 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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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.
Yuqin Song, M.D. principal investigator
Beijing university cancer hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM355 in people with Hematoma, run by Beijing InnoCare Pharma Tech Co., Ltd. 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 11 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Dose-limiting toxicities (DLT) (time frame: Up to 2 year). The study lists 4 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 27 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.