A Two Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection (ABMR).

NCT07641426 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CASI-CID-103-203
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Antibody Mediated Rejection

Outcome Measures

Primary Outcomes (5)

• Arms A: Number of participants experiencing study-specific safety events or meeting treatment stopping criteria

  Up to Week 65

• Arms A: Number of participants with AEs with focus on infections, cytopenias, and IRRs

  Up to Week 65

• Arms A: Number of Participants With Serious Adverse Events (SAEs)

  Up to Week 65

• Arms A: Number of Participants With Anti-Drug Antibody (ADA)

  Up to week 65

• Part B: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 24

  at Week 24

Secondary Outcomes (13)

• Part A: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 24 and Week 52

  at Week 24 and Week 52

• Part B: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 52

  Week 52

• Arms A and B: Number of Participants with Changes From Baseline in Any Clinically Significant Laboratory Abnormalities

  up to Week 65

• Arms A and B: Change From Baseline in Urine Protein Creatinine Ratio (UPCR)

  Up to Week 65

• Part A and B: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

  Up to Week 65

Study Arms (4)

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.

Drug: CID-103

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.

Drug: CID-103

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.

Drug: CID-103

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.

Drug: CID-103

Interventions

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.

Part A (Dose Escalation) Cohort 1- 150 mg/300 mg; Part A (Dose Escalation) Cohort 2- 150 mg/600 mg; Part A (Dose Escalation) Cohort 3- 150 mg/900 mg; Part B cohort- 150 mg/dose selected from Part A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• HLA class I and/or II antigen-specific antibodies (preformed and/or dnDSA).
• Existing diagnosis of active or chronic/active ABMR (± C4d in peritubular capillaries) within the last 180 days according to the Banff 2022 classification as per local pathology read.
• Must have a renal biopsy within 28 days (preferably within 14 days) of first study drug administration for central pathology review. Results of the central pathology review are not required prior to first study drug administration.
• Participants who have been diagnosed with pre-existing HLA class I/II DSA at the time of their original renal allograft transplant must have received prior treatment with intravenous immune globulin (IVIG) and plasmapheresis (unless contraindicated).
• Participants with active ABMR may have received prior treatment with IVIG and plasmapheresis (not required).
• For participants that have received prior IVIG, subcutaneous immunoglobulin (SCIg), plasmapheresis, complement system inhibitors (e.g., eculizumab), proteasome inhibitors (e.g., bortezomib) or an interleukin-6 inhibitor (e.g. tocilizumab), or an anti-CD20 (e.g., rituximab) a washout period ≥12 weeks is required prior to first study drug administration
• Standardized immune suppression regimen.
• Adequate organ function without transfusions, within 14 days of first dose of study drug.
• Contraception.

You may not qualify if:

• ABO-incompatible transplant.
• Any of the following on baseline biopsy:
• T-cell-mediated rejection classified Banff Grade ≥ 1.
• de novo or recurrent severe thrombotic microangiopathy.
• polyoma virus nephropathy.
• de novo or recurrent glomerulonephritis.
• Acute rejection treatment within 180 days of dosing.
• Contraindication to repeat biopsies.
• Previous treatment with other anti-CD38 monoclonal antibodies.
• Other immunomodulatory antibodies within ≤ 90 days of dosing.
• Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of study drug or five half-lives (if shorter).
• Participants unable to modify baseline immune suppression.
• Active viral, bacterial, or fungal infection precluding intensified immunosuppression.
• Known latent or active tuberculosis.
• Known active infection with human immunodeficiency virus (HIV).

Sponsors & Collaborators

• CASI pharmaceuticals, Inc.: lead
• CASI Pharmaceuticals (China) Co., Ltd.: collaborator

Study Sites (4)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Study Officials

• Junping Chen

  CASI pharmaceuticals, Inc.

  STUDY CHAIR

Central Study Contacts

Junping Chen

CONTACT

202-617-6071; junpingc@casipharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CN (4)