The goal of the global Phase 1/2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with with active and chronic active renal allograft antibody mediated rejection (ABMR). The main questions the study aims to answer are:• To evaluate the safety and tolerability of CID-103 in subjects with ABMR with different increasing doses of CID-103.• To evaluate clinical efficacy of CID-103 at an optimal dose in participants with active and chronic active ABMR following renal allograft transplant. The study will be done in two parts: Part A will test increasing doses of CID-103 to see how safe it is and how well people tolerate it. Researchers will also aim to find a safe dose range. Part B will enroll approximately 40 participants to see how well the medicine works and gather more safety and efficacy information. The goal is to find the optimal dose to use in future studies.CID-103 is given through an intravenous (IV) infusion. During the study, participants may receive treatment for up to 12 months, followed by a post-treatment safety follow-up period to check for ongoing safety and effectiveness. This study is an important step toward developing a new treatment for people living with ABMR. If CID-103 is found to be safe and effective, it could offer a new option for patients who do not respond well to current therapies.
At least 18 years old at time of signing of ICF.
Voluntary, written, informed consent prior to study-specific procedures.
Functioning living or deceased donor renal allograft ≥ 180 days post-transplant.
eGFR ≥ 25 mL/min/1.73 m2 chronic kidney disease epidemiology collaboration (CKD-EPI 2021, see APPENDIX A).
ABO-incompatible transplant.
T-cell-mediated rejection classified Banff Grade ≥ 1.
de novo or recurrent severe thrombotic microangiopathy.
polyoma virus nephropathy.
Sequential
CID-103
DrugFollowing 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.
Arms A: Number of participants experiencing study-specific safety events or meeting treatment stopping criteria
Arms A: Number of participants with AEs with focus on infections, cytopenias, and IRRs
Arms A: Number of Participants With Serious Adverse Events (SAEs)
Arms A: Number of Participants With Anti-Drug Antibody (ADA)
Part A: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 24 and Week 52
Part B: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 52
Arms A and B: Number of Participants with Changes From Baseline in Any Clinically Significant Laboratory Abnormalities
Arms A and B: Change From Baseline in Urine Protein Creatinine Ratio (UPCR)
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CASI pharmaceuticals, Inc.
Lead sponsor
CASI Pharmaceuticals (China) Co., Ltd.
Collaborator
