Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-02
First Post:
2021-02-08
Brief Title:
CID-103 Anti-CD38 Antibody in Previously Treated Relapsed or Refractory Multiple Myeloma
Sponsor:
CASI Pharmaceuticals Inc
Organization:
CASI Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Dose Escalation and Expansion Study of CID-103 an Anti-CD38 Antibody in Patients With Previously Treated Relapsed or Refractory Multiple Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with relapsedrefractory 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
Detailed Description:
Dose escalationinfusion duration phase
During the CID-103 dose escalationinfusion 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 relapsedrefractory 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
During the CID-103 dose escalationinfusion 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 relapsedrefractory 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004006-10 | EUDRACT_NUMBER | None | None |