Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma
NCT ID: NCT04818372
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
87 participants
INTERVENTIONAL
2021-04-26
2023-04-30
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation
Subjects enrolled in this arm will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals.
Dose escalation will be carried out according to a modified 3+3 dose-escalation design. Accelerated dose titration design will be used for the first 4 dose levels (0.006mg/kg, 0.06mg/kg, 0.3mg/kg and 1.0mg/kg) and then traditional 3+3 dose escalation design will be used for the following levels (2.0mg/kg, 4.0mg/kg, 8.0mg/kg, 16mg/kg and 24mg/kg).
CM313-Dose escalation
Subjects will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals.
Dose expansion _Cohort 1
This cohort will comprise subjects with RRMM. Subjects will receive the CM313 in combination with dexamethasone.
CM313
Subjects will have 8 infusions at weekly intervals, and then 8 infusions at bi-weekly intervals. After that CM313 will be given every 4 weeks until disease progression or unacceptable toxicity.
Dexamethasone
dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
Dose expansion _Cohort 2
This cohort will comprise subjects with RRMM and NDMM. Subjects will receive the CM313 in combination with Rd regimen.
CM313
Subjects will have 8 infusions at weekly intervals, and then 8 infusions at bi-weekly intervals. After that CM313 will be given every 4 weeks until disease progression or unacceptable toxicity.
Dexamethasone
dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
Lenalidomide
25 mg/day lenalidomide 21 of 28 days cycle
Interventions
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CM313-Dose escalation
Subjects will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals.
CM313
Subjects will have 8 infusions at weekly intervals, and then 8 infusions at bi-weekly intervals. After that CM313 will be given every 4 weeks until disease progression or unacceptable toxicity.
Dexamethasone
dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
Lenalidomide
25 mg/day lenalidomide 21 of 28 days cycle
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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%.
18 Years
75 Years
ALL
No
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Wenming Chen, Dr.
Role: PRINCIPAL_INVESTIGATOR
Beijing Chao Yang Hospital
Locations
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Beijing Chao-Yang Hospital, Capital Medical University (West Branch)
Beijing, Beijing Municipality, China
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhongxia Huang
Role: primary
Wenming Chen, Dr.
Role: primary
Hongmei Jing, Dr.
Role: primary
Other Identifiers
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CM313MM001
Identifier Type: -
Identifier Source: org_study_id