Antibody Mediated RejectionPhase 1/2NCT07641426
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).
A Phase 1/2 study testing CID-103 in people with Antibody Mediated Rejection, run by CASI pharmaceuticals, Inc. at 4 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibody Mediated Rejection
- What is being tested?
- CID-103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesChina
- Study dates
- 9 Jun 2026to Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- Known active infection.
- IgG < 400 mg/dL.
- Other chronic or acute disease(s) likely to interfere with study endpoint evaluation.
- Active malignant disease or premalignant condition within two years, precluding intensified immunosuppressive therapy.
- Administration of a live vaccine ≤ 6 weeks of screening.
- Participation in interventional component of another clinical trial.
- History or clinical evidence of any surgical or medical condition which the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, particularly any pre-existing condition that would put the participant at additional risk should they experience an IRR.
- Any unresolved treatment-related AE(s) from prior treatment that have not resolved to Grade 1 or baseline value prior to first dose of study drug.
- Known hypersensitivity to CID-103 excipients or prior severe hypersensitivity to a monoclonal antibody.
- Participants who experienced a Grade 3 or 4 AE related to prior administration of monoclonal antibodies, which the Investigator feels may recur and/or put the participant at significant risk, should be excluded.
- Previous Grade 4 anaphylactic reaction to other therapeutic proteins.
- Chronic dependence on transfusions or hematopoietic growth factors to maintain acceptable blood counts excluding those participants who require ESAs for documented erythropoietin deficiency. Participants cannot have had a transfusion within the past 14 days prior to first dose of study drug or have had more than 1 transfusion in the past month.
- Inability to perform study baseline red blood cell (RBC) type and crossmatch, phenotype (and genotype, if applicable) or lack of available baseline data on RBC phenotype (or genotype, if applicable).
- Unable or not willing to agree to the evaluation of RBC antigens by phenotyping or genotyping.
- Unable or not willing to comply with the protocol and the visit schedule restrictions and assessments therein.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 1 recruiting
- Active, not recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality
- Active, not recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Gang Chen, +86 27 83662379, gchentj@163.com
- Active, not recruiting
The First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, Shaanxi
About this study
Official title: A 2 Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection.
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
- Being tested
- CID-103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CID-103Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: CID-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arms A: Number of participants experiencing study-specific safety events or meeting treatment stopping criteria
Measured: Up to Week 65
Arms A: Number of participants with AEs with focus on infections, cytopenias, and IRRs
Measured: Up to Week 65
Arms A: Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to Week 65
Arms A: Number of Participants With Anti-Drug Antibody (ADA)
Measured: Up to week 65
Part B: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 24
Measured: 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
Measured: at Week 24 and Week 52
Part B: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 52
Measured: Week 52
Arms A and B: Number of Participants with Changes From Baseline in Any Clinically Significant Laboratory Abnormalities
Measured: up to Week 65
Arms A and B: Change From Baseline in Urine Protein Creatinine Ratio (UPCR)
Measured: Up to Week 65
Part A and B: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Up to Week 65
Arms A and B: Change From Baseline in Urine Protein
Measured: Up to Week 65
Arms B: Number of participants with AEs with focus on infections, cytopenias, and IRRs
Measured: Up to Week 65
Arms B: Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to Week 65
Arms A and B: Change From Baseline in Donor-Specific-Antibodies (DSA)
Measured: Up to Week 65
Arms A and B: Change From Baseline in Donor-Derived Cell-Free DNA (dd-cfDNA)
Measured: up to week 65
Part A and B: Number of Participants With All-cause Allograft Failure After Treatment of CID-103
Measured: Up to Week 65
Part A and B: Percentage of Participants Survival Rate at Week 65
Measured: Up to Week 65
Parts A and B: CID-103 Serum Concentrations
Measured: Up to Week 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start9 Jun 2026
- Primary completionMay 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody Mediated RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CASI Pharmaceuticals (China) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Junping Chen, Study chair, CASI pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641426
- Sponsor's protocol ID
- CASI-CID-103-203
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection.
- ClinicalTrials.gov ID
- NCT07641426
- Acronym / sponsor ID
- CASI-CID-103-203
- Conditions
- Antibody Mediated Rejection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CASI Pharmaceuticals (China) Co., Ltd.
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A (Dose Escalation) Cohort 1- 150 mg/300 mg | Experimental | Drug: CID-103This 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 | Drug: CID-103This 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 | Drug: CID-103This 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 | Drug: CID-103Following an initial priming dose of 150 mg on Week 1, participants will receive CID-103 at their target dose administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (30 listed)
- ABO-incompatible transplant.
- Any of the following on baseline biopsy:
- Acute rejection treatment within 180 days of dosing.
- Contraindication to repeat biopsies.
- Previous treatment with other anti-CD38 monoclonal antibodies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CID-103Following 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. | Drug | 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 |
Primary outcome
Arms A: Number of participants experiencing study-specific safety events or meeting treatment stopping criteria
Time frame: Up to Week 65
Arms A: Number of participants with AEs with focus on infections, cytopenias, and IRRs
Time frame: Up to Week 65
Arms A: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 65
Arms A: Number of Participants With Anti-Drug Antibody (ADA)
Time frame: Up to week 65
Part B: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 24
Time frame: at Week 24
13 secondary outcomes
Part A: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 24 and Week 52
Time frame: at Week 24 and Week 52
Part B: Number of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 52
Time frame: Week 52
Arms A and B: Number of Participants with Changes From Baseline in Any Clinically Significant Laboratory Abnormalities
Time frame: up to Week 65
Arms A and B: Change From Baseline in Urine Protein Creatinine Ratio (UPCR)
Time frame: Up to Week 65
Part A and B: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Up to Week 65
Arms A and B: Change From Baseline in Urine Protein
Time frame: Up to Week 65
Arms B: Number of participants with AEs with focus on infections, cytopenias, and IRRs
Time frame: Up to Week 65
Arms B: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 65
Arms A and B: Change From Baseline in Donor-Specific-Antibodies (DSA)
Time frame: Up to Week 65
Arms A and B: Change From Baseline in Donor-Derived Cell-Free DNA (dd-cfDNA)
Time frame: up to week 65
Part A and B: Number of Participants With All-cause Allograft Failure After Treatment of CID-103
Time frame: Up to Week 65
Part A and B: Percentage of Participants Survival Rate at Week 65
Time frame: Up to Week 65
Parts A and B: CID-103 Serum Concentrations
Time frame: Up to Week 65
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junping Chen study chair
CASI pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CID-103 in people with Antibody Mediated Rejection, run by CASI pharmaceuticals, Inc. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junping Chen (202-617-6071, junpingc@casipharmaceuticals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arms A: Number of participants experiencing study-specific safety events or meeting treatment stopping criteria (time frame: Up to Week 65). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.