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

NCT05210868 | Active Not Recruiting Phase 1

• 1 other identifier: CM355-001
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I/II Open-Label, Single-Arm, Multicenter Clinical Study of CM355 in Patients With R/R B-NHL

Conditions

Hematoma

Outcome Measures

Primary Outcomes (4)

• Dose-limiting toxicities (DLT)

  Incidence, nature, and severity of dose-limiting toxicities.

  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.

  Up to 2 year

• Objective response rate（ORR）

  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

  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 Outcomes (11)

• Peak Plasma Concentration (Cmax)

  Every cycle (21 days), until the end of treatment

• Area under the plasma concentration versus time curve (AUC)

  Every cycle (21 days), until the end of treatment

• Peak time

  Every cycle (21 days), until the end of treatment

• T1/2

  Every cycle (21 days), until the end of treatment

• Clearanc (CL)

  Every cycle (21 days), until the end of treatment

Other Outcomes (1)

• Cytokines

  Up to 17 cycles （21 days per cycle)

Study Arms (1)

CM355

EXPERIMENTAL

1. Dose Escalation Phase CM355 2. Dose Expansion Phase CM355

Drug: CM355

Interventions

CM355 DRUG

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

CM355

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

Beijing university cancer hospital

Beijing, China

Location

MeSH Terms

Conditions

Hematoma

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuqin Song, M.D.

  Beijing university cancer hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 27, 2022
• Study Start: November 16, 2021
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 27, 2022

Record last verified: 2021-11

Locations

CN (1)