Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CID-103 · 3 trials · 3 indications
* Occurrence of DLTs (Part A only) * Frequency of TEAEs * Related AEs * Grade 3/4 AEs * Serious adverse events (SAEs) * Fatal AEs * AEs leading to CID-103 discontinuation up to Week 12 * Percentage of subjects with at least one treatment-related Grade ≥ 3 TEAE, SAE or AE leading to CID-103 discontinuation up to Week 12 (Part B only)
A platelet count ≥ 50 x 10\^9/L and ≥ 20 x 10\^9/L above baseline achieved on at least two consecutive measurements at least seven days apart.
CTCAE v5 coded using the current Medical Dictionary for Regulatory Activities (MedDRA) version
| Arm | Type | Description |
|---|---|---|
| Part A (Dose Escalation) Cohort 1- 150 mg/300 mg | EXPERIMENTAL | This is the initial dose cohort with accelerated dose escalation design. If ≥ 1 out of the 3 participants in the cohort experience a related Grade ≥3 AE or study-specific safety event, the cohort will expand to 6 participants. |
| Part A (Dose Escalation) Cohort 2- 150 mg/600 mg | EXPERIMENTAL | This is the second dose cohort with accelerated dose escalation design. If ≥ 1 out of the 3 participants in the cohort experience a related Grade ≥3 AE or study-specific safety event, the cohort will expand to 6 participants. |
| Part A (Dose Escalation) Cohort 3- 150 mg/900 mg | EXPERIMENTAL | This is the third dose cohort with accelerated dose escalation design. If ≥ 1 out of the 3 participants in the cohort experience a related Grade ≥3 AE or study-specific safety event, the cohort will expand to 6 participants. |
| Part B cohort- 150 mg/dose selected from Part A | EXPERIMENTAL | Following an initial priming dose of 150 mg on Week 1, participants will receive CID-103 at their target dose administered. |
| Part B (Randomized Dose Exploration) high-dose cohort | EXPERIMENTAL | Each participant will receive selected high-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. |
| Part B (Randomized Dose Exploration) intermediate-dose cohort | EXPERIMENTAL | Each participant will receive selected intermediate-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. |
| Part B (Randomized Dose Exploration) low-dose cohort | EXPERIMENTAL | Each participant will receive selected low-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment. |
| Part A (Dose Escalation) Cohort 1- 30 mg/30 mg | EXPERIMENTAL | This is the initial dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 30 mg/150 mg | EXPERIMENTAL | This is the second dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 150 mg/600 mg | EXPERIMENTAL | This is the fourth dose cohort with standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 150 mg/900 mg | EXPERIMENTAL | This is the fifth dose cohort with standard 3+3 design. |
| 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 |
|---|---|---|
| CID-103 | DRUG | Following an initial priming dose of 150 mg on Week 1, participants will receive CID-103 at the higher target dose administered for up to a maximum treatment duration of 49 weeks, in the absence of treatment failure or stopping criteria. |
Inclusion Criteria: 1. At least 18 years old at time of signing of ICF. 2. Voluntary, written, informed consent prior to study-specific procedures. 3. Functioning living or deceased donor renal allograft ≥ 180 days post-transplant. 4. eGFR ≥ 25 mL/min/1.73 m2 chronic kidney disease epidemiology col...
CID-103 is an investigational small molecule being studied for multiple myeloma, chronic immune thrombocytopenia, and antibody mediated rejection. It is in Phase 1 clinical development for these conditions.
CID-103 targets CD38, a protein. It is being developed as a therapeutic agent for conditions including multiple myeloma, chronic immune thrombocytopenia, and antibody mediated rejection.
CID-103 is being developed by CASI Pharmaceuticals, Inc., a company traded on NASDAQ under the ticker CASI.
CID-103 is in Phase 1 clinical development. It is investigational and not yet approved for any use. Clinical trials are ongoing or completed for multiple myeloma, chronic immune thrombocytopenia, and antibody mediated rejection.
CID-103 has been studied in NCT04758767 for relapsed or refractory multiple myeloma, which is completed. It is also being studied in NCT07017725 for chronic immune thrombocytopenia and NCT07641426 for antibody mediated rejection, both currently recruiting.