CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Myeloma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Single arm dose escalation, followed by dose expansion arm (2 cohorts)Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 a...
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.
Tracking Information
- NCT #
- NCT04758767
- Collaborators
- Not Provided
- Investigators
- Study Director: Alexander Zukiwski, MD CASI Pharmaceuticals, Inc.