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Tests treatment safety and results for Antibody Mediated Rejection
Official title 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).
ClinicalTrials.gov ID: NCT07641426
What this study is testing
What is CID-103?
CID-103 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for antibody mediated rejection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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).
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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...
- 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...
- Standardized immune suppression regimen.
- Adequate organ function without transfusions, within 14 days of first dose of study drug.
- Contraception.
- 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).
- 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 treatment 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Wuhan, Hubei, China; Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.