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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
anti-CD38 antibody
CHU de Nantes - Hôpital Hôtel-Dieu
Nantes, France
CHU Rennes - Pontchaillou
Rennes, France
Gustave Roussy Cancer Center
Villejuif, France
Sarah Cannon
London, United Kingdom
Adverse events
CTCAE v5 coded using the current Medical Dictionary for Regulatory Activities (MedDRA) version
Time frame: approximately 18 months after study start
Recommended Phase 2 dose
Based primarily on dose-limiting toxicities
Time frame: 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
Time frame: approximately 18 months after study start
Target engagement assays and ex vivo testing
Extent of RBC binding and cross-match confounding
Time frame: approximately 18 months after study start
PK - AUC of CID-103
AUC of CID-103 in serum
Time frame: approximately 18 months and 3 years after study start
PK - Cmax of CID-103
Cmax of CID-103 in serum
Time frame: approximately 18 months and 3 years after study start
PK - t1/2 of CID-103
half-life of CID-103 in serum
Time frame: approximately 18 months and 3 years after study start
PK - Vd of CID-103
volume of distribution of CID-103 in serum
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Time frame: approximately 18 months and 3 years after study start
PK - accumulation of CID-103
accumulation of CID-103 in serum
Time frame: approximately 18 months and 3 years after study start
Objective response rate
Based on IMWG
Time frame: 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
Time frame: 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
Time frame: approximately 3 years after study start
Overall survival
Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG
Time frame: approximately 3 years after study start