A Phase I/II Study of CM355 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)

January 10, 2022 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged ≥ 18 years old.
  2. Eastern Cooperative Oncology Group (ECOG, see Appendix 3) PS score of 0-1.
  3. Histopathologically confirmed relapsed or refractory B-cell NHL has been confirmed or anticipated to express CD20 in lymphoma lesions.
  4. According to Lugano criteria, imaging evaluation shows at least one bidimensionally measurable lesion.
  5. 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
  6. Expected survival ≥ 3 months.
  7. All toxicities caused by prior anticancer therapy must have recovered to grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.
  8. Female patients with childbearing potential should have a negative blood pregnancy test result within 7 days prior to the first dose.
  9. 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.
  10. Female patients cannot breastfeed or plan to become pregnant during the study until at least 6 months after the last dose of investigational drug.
  11. The patient voluntarily joined the study and signed the ICF.

Exclusion Criteria:

  1. Active or past central nervous system (CNS) lymphoma.
  2. Other active malignancies occurring within 5 years prior to the first dose of investigational drug, with the exception of radically treated local curable cancers.
  3. The patient has a disease or medical history that needs to be excluded as specified in the Clinical Trial Protocol.
  4. Any active infection requiring systemic therapy via intravenous infusion within 14 days prior to the first dose of investigational drug.
  5. 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.
  6. Any severe or uncontrolled systemic disease.
  7. 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.

  8. 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:

  9. Having received allogeneic hematopoietic stem cell transplantation or received auto-HSCT within 100 days prior to the first dose.
  10. Active bleeding within 2 months prior to screening, or receiving anticoagulants, or other bleeding symptoms requiring medical intervention.
  11. 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.
  12. 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.
  13. Patients who have received any other investigational anti-cancer drug therapy within 28 days prior to the first dose.
  14. 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.
  15. 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.
  16. 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.
  17. Known alcoholism or drug abuse history.
  18. Other conditions determined by the investigator that render patients unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CM355
  1. Dose Escalation Phase CM355
  2. Dose Expansion Phase CM355
Drug: CM355
  1. 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicities (DLT)
Time Frame: Up to 2 year
Incidence, nature, and severity of dose-limiting toxicities.
Up to 2 year
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.
Up to 2 year
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)
through study completion，an average of 5 year
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.
through study completion，an average of 5 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: Every cycle (21 days), until the end of treatment
Dose Escalation peak plasma concentration (ng/mL)
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
Dose Escalation AUC（μg·h/mL）
Every cycle (21 days), until the end of treatment
Peak time
Time Frame: Every cycle (21 days), until the end of treatment
Time of maximum observed plasma concentration (Tmax)
Every cycle (21 days), until the end of treatment
T1/2
Time Frame: Every cycle (21 days), until the end of treatment
Terminal half-life of CM355
Every cycle (21 days), until the end of treatment
Clearanc (CL)
Time Frame: Every cycle (21 days), until the end of treatment
Total body clearance of the drug from plasma (CL) of CM355
Every cycle (21 days), until the end of treatment
Anti-CM355 antibodies (ADAs)
Time Frame: Every cycle (21 days), until the end of treatment
Incidence of anti-CM355 antibodies (ADAs) and their correlation with clinical outcomes.
Every cycle (21 days), until the end of treatment
Objective response rate (ORR)
Time Frame: through study completion，an average of 5 year
Objective response rate (ORR) as assessed by investigators
through study completion，an average of 5 year
Complete response rate (CRR)
Time Frame: through study completion，an average of 5 year
Complete response rate (CRR) as assessed by investigators or independent review committee (IRC)
through study completion，an average of 5 year
Duration of response (DOR)
Time Frame: through study completion，an average of 5 year
Duration of response (DOR) as assessed by investigators or Independent review committee (IRC)
through study completion，an average of 5 year
Progression-Free-Survival (PFS)
Time Frame: through study completion，an average of 5 year
Progression-Free-Survival (PFS) as assessed by investigators or independent review committee (IRC)
through study completion，an average of 5 year
overall survival (OS)
Time Frame: through study completion，an average of 5 year
overall survival (OS) as assessed by investigators or independent review committee (IRC)
through study completion，an average of 5 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cytokines
Time Frame: Up to 17 cycles （21 days per cycle)
To conduct qualitative and quantitative analyses of the level of changes in cytokines (IL-2, IL-6, IL-10, INF-γ, and TNF-α).
Up to 17 cycles （21 days per cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuqin Song, M.D., Beijing University Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2026

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CM355-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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