Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma

Last updated: November 11, 2021
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Multiple Myeloma

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT04818372
CM313MM001
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CM313.

The dose escalation part will determine the MTD of CM313 in subjects with relapsed and/or refractory multiple myeloma (RRMM) or lymphoma based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design).

The dose expansion part includes two cohorts. Cohort 1 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Dexamethasone in subjects with RRMM. Cohort 2 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Rd regimen (Lenalidomide/Dexamethasone) in subjects with RRMM or newly diagnosed MM (NDMM).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Dose escalation: subjects with RRMM who have progressed on, or could not tolerate, allavailable established therapies and subjects with recurrent and refractory lymphoma.
  • Dose expansion_cohort 1: subjects with RRMM who have progressed on, or could nottolerate, all available established therapies.
  • Dose expansion_cohort 2: subjects with RRMM who have progressed on, or could nottolerate, all available established therapies, or subjects with NDMM.
  • For MM: Documented initial diagnosis of multiple myeloma according to InternationalMyeloma Working Group (IMWG) diagnostic criteria.
  • For MM: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum orthe urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serumimmunoglobulin kappa lambda FLC ratio.
  • Eastern Cooperative Oncology Group (ECOG) performance status score <＝2.
  • Women of childbearing potential and male subjects must agree to remain abstinent oruse contraceptive methods as defined by the protocol.
  • Side effects of any prior therapy or procedures for any medical condition hasrecovered to NCI-CTCAE v.5.0 Grade ≤ 1.

Exclusion

Key Exclusion Criteria:

  • Previous treatment with any anti-CD38 therapy.
  • Subjects with concurrent plasma cell leukemia.
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose ofstudy drug (does not include pretreatment medication).
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
  • Received an allogenic stem cell transplant or an autologous stem cell transplantwithin 3 months before first dose of study drug.
  • Central nervous system (CNS) involvement.
  • The forced expiratory volume in one second (FEV1)<60%.

Study Design

Total Participants: 87
Study Start date:
April 26, 2021
Estimated Completion Date:
April 30, 2023

Connect with a study center

  • Beijing Chao-Yang Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Beijing Chao-Yang Hospital, Capital Medical University (West Branch)

    Beijing, Beijing
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing
    China

    Site Not Available

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