Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004006-10 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities.
Dose escalation/infusion duration phase:
During the CID-103 dose escalation/infusion duration phase, only patients diagnosed with multiple myeloma who have relapsed or are refractory to at least two prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody will be enrolled. Patients will receive monotherapy CID-103. Dose escalation decisions will be based on dose-limiting toxicities; infusion duration decisions will be based on infusion-related reactions. The dose taken forward into the expansion phase will be the RP2D determined in the dose escalation phase.
Expansion phase:
The expansion phase consists of two specific cohorts of patients with relapsed/refractory multiple myeloma: 1) Pretreated cohort having received previous treatment with an anti-CD38 antibody and 2) Naïve cohort in patients for whom an anti-CD38 antibody is unavailable. Eight patients will be enrolled into each cohort, and if one or more responses is observed, that cohort will be expanded to a total of 14 patients to further assess efficacy. Patients must have had at least two prior systemic therapies (mono or combo), including a proteasome inhibitor and an immunomodulatory agent. Patients will be treated until disease progression or unacceptable toxicities.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation cohort | Experimental | Monotherapy CID-103. Priming dose will be given for first dose. Dose and duration of infusion dependent on dose cohort and tolerability. |
|
| Dose expansion cohort - pretreated | Experimental | CID-103 monotherapy at the recommended phase 2 dose |
|
| Dose expansion cohort - Naïve | Experimental | CID-103 monotherapy at the recommended phase 2 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CID-103 | Drug | anti-CD38 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | CTCAE v5 coded using the current Medical Dictionary for Regulatory Activities (MedDRA) version | approximately 18 months after study start |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 dose | Based primarily on dose-limiting toxicities | approximately 18 months after study start |
| Optimal pre- and post-medication regimens | Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities will be compared before and after the changes in pre/post medications are made, with specific focus on IRRs and their symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Target binding of CID-103 | Target binding on different circulating blood cell populations and the potential PD markers | approximately 3 years after study start |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Zukiwski, MD | Casi Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes - Hôpital Hôtel-Dieu | Nantes | France | ||||
| CHU Rennes - Pontchaillou |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Single arm dose escalation, followed by dose expansion arm (2 cohorts)
Not provided
Not provided
Not provided
Not provided
| approximately 18 months after study start |
| Target engagement assays and ex vivo testing | Extent of RBC binding and cross-match confounding | approximately 18 months after study start |
| PK - AUC of CID-103 | AUC of CID-103 in serum | approximately 18 months and 3 years after study start |
| PK - Cmax of CID-103 | Cmax of CID-103 in serum | approximately 18 months and 3 years after study start |
| PK - t1/2 of CID-103 | half-life of CID-103 in serum | approximately 18 months and 3 years after study start |
| PK - Vd of CID-103 | volume of distribution of CID-103 in serum | approximately 18 months and 3 years after study start |
| PK - accumulation of CID-103 | accumulation of CID-103 in serum | approximately 18 months and 3 years after study start |
| Objective response rate | Based on IMWG | approximately 3 years after study start |
| Duration of response | Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG | approximately 3 years after study start |
| Progression-free survival | Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG | approximately 3 years after study start |
| Overall survival | Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG | approximately 3 years after study start |
| Rennes |
| France |
| Gustave Roussy Cancer Center | Villejuif | France |
| Sarah Cannon | London | United Kingdom |
| 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 |