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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | 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). |
|
| Dose expansion _Cohort 1 | Experimental | This cohort will comprise subjects with RRMM. Subjects will receive the CM313 in combination with dexamethasone. |
|
| Dose expansion _Cohort 2 | Experimental | This cohort will comprise subjects with RRMM and NDMM. Subjects will receive the CM313 in combination with Rd regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM313-Dose escalation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose escalation: Number of Participants with a Dose-Limiting Toxicity (DLT) | Up to 21 days after the first dose | |
| Dose escalation and Dose expansion: Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | Up to 30 days after the last dose of CM313 or until the start of subsequent anticancer therapy, if earlier | |
| Dose expansion: To evaluate the activity of CM313 in combination with Rd/Dexamethasone as assessed by overall response rate (ORR) in RRMM patients | ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose escalation: AUC to the last quantifiable concentration [AUC(0-last)], over the dosing interval [AUC(0-tau)], extrapolated to infinity [AUC(0-inf), time to Cmax (tmax), apparent half-life (t1/2), systemic clearance (CL). | 21 days after the first dose | |
| Dose escalation and Dose expansion: AUC(0-last), AUC(0-tau), Cmax, t1/2, systemic clearance (CL), volume of distribution (Vz, Vss), minimum concentration (Cmin), Ctrough, accumulation ratios for Cmax and AUC(0-tau) for multiple doses |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com | |
| Dan Liu | Contact | 028-88610620 | danliu@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenming Chen, Dr. | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University (West Branch) | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Dose Escalation: Modified 3+3 dose escalation design: an accelerated dose titration design followed by traditional 3+3 dose escalation design
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| CM313 | Drug | 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 | Drug | dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle |
|
| Lenalidomide | Drug | 25 mg/day lenalidomide 21 of 28 days cycle |
|
| up to 24 months |
| Dose escalation and Dose expansion: Incidence of anti-CM313 | up to 24 months |
| Dose escalation: Overall Response Rate (ORR) | ORR is defined as the proportion of participants who have a partial response (PR) or better according to the IMWG criteria. | up to 24 months |
| Dose escalation and Dose expansion: Clinical Benefit Rate (CBR) | CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria. | up to 24 months |
| Dose escalation and Dose expansion: Duration of Response (DOR) | DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.or better according to the IMWG criteria. | From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months) |
| Dose escalation and Dose expansion: Time to Response (TTR) | TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. | From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months) |
| Dose escalation and Dose expansion: Progression-Free Survival (PFS) | PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. | up to 24 months |
| Beijing Chao-Yang Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking University Third Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |