Status:
UNKNOWN
Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Multiple Myeloma
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 w...
Eligibility Criteria
Inclusion
- Key
- Dose escalation: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies and subjects with recurrent and refractory lymphoma.
- Dose expansion\_cohort 1: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies.
- Dose expansion\_cohort 2: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies, or subjects with NDMM.
- For MM: Documented initial diagnosis of multiple myeloma according to International Myeloma 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 or the urine: serum immunoglobulin free light chain (FLC) \>= 10 mg/dL and abnormal serum immunoglobulin 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 or use contraceptive methods as defined by the protocol.
- Side effects of any prior therapy or procedures for any medical condition has recovered to NCI-CTCAE v.5.0 Grade ≤ 1.
- Key
Exclusion
- 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 of study 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 transplant within 3 months before first dose of study drug.
- Central nervous system (CNS) involvement.
- The forced expiratory volume in one second (FEV1)\<60%.
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04818372
Start Date
April 26 2021
End Date
April 1 2023
Last Update
November 12 2021
Active Locations (3)
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1
Beijing Chao-Yang Hospital, Capital Medical University (West Branch)
Beijing, Beijing Municipality, China
2
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
3
Peking University Third Hospital
Beijing, Beijing Municipality, China