NCT06126237

Brief Summary

This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_1 multiple-myeloma

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

November 13, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

November 6, 2023

Last Update Submit

November 6, 2023

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Adverse event

    Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    up to 18 months

Study Arms (2)

CM313

EXPERIMENTAL

CM313 injection, subcutaneous

Biological: CM313 injection

CM313 + concomitant medication

EXPERIMENTAL

CM313 injection, subcutaneous

Biological: CM313 injection

Interventions

CM313 injectionBIOLOGICAL

CM313, subcutaneous injection

CM313CM313 + concomitant medication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects age ≥ 18 years.
  • Subjects diagnosed with multiple myeloma.
  • Subjects with measurable lesions.
  • Women of childbearing potential with negative pregnancy testing.
  • Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

You may not qualify if:

  • Previous treatment with any anti-CD38 therapy.
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
  • Positive for human immunodeficiency virus (HIV) antibodies.
  • Syphilis antibody positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 13, 2023

Study Start

February 28, 2024

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

November 13, 2023

Record last verified: 2023-10