Anti-CD38 Antibody Treating APS With Thrombocytopenia
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ClinicalTrials.gov Identifier: NCT05983952 |
Recruitment Status :
Recruiting
First Posted : August 9, 2023
Last Update Posted : August 14, 2023
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Condition or disease | Intervention/treatment | Phase |
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Antiphospholipid Syndrome Thrombocytopenia | Drug: Anti-CD38 antibody Injection | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia |
Estimated Study Start Date : | August 2023 |
Estimated Primary Completion Date : | August 2025 |
Estimated Study Completion Date : | August 2025 |
Arm | Intervention/treatment |
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Experimental: Intervention(Anti-CD38 antibody)
10 enrolled subjects: once a week x 8 doses
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Drug: Anti-CD38 antibody Injection
intravenous Anti-CD38 antibody administration This study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks. The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment. The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment. |
- To evaluate the efficacy after CM313 treatment within 8 weeks [ Time Frame: 8 weeks ]Proportion of subjects with a platelet count ≥ 50 × 10^9/L within 8 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
- Safety of anti-CD38 antibody [ Time Frame: 24 weeks ]Incidence, severity, and relationship of treatment emergent adverse events after anti-CD38 antibody treatment
- Response rate of treatment [ Time Frame: 12 weeks ]Including: 1. Proportion of subjects with a platelet count ≥ 50 × 10^9/L at week 2, week 4, week 6,week 8,week 10 and week 12 in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period; 2. Proportion of subjects achieving platelet counts ≥ 50×10^9/L at least once in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the first 12 weeks; 3. Proportion of subjects whose platelet counts ≥ 30×10^9/L and at least two times of baseline platelet count in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids within 8 weeks(two consecutive measurements at least 7 days apart).
- Duration from treatment initiation to platelet count ≥50×10^9/L [ Time Frame: 12 weeks ]Duration from treatment initiation to platelet count ≥50×10^9/L without having received any platelet elevating therapy or having had dose increment of TPO-RA and/or corticosteroids
- Duration of platelet response [ Time Frame: 24 weeks ]The longest duration for which the subject sustained a platelet count ≥50×109/L
- platelet count ≥50×10^9/L ≥75% tests [ Time Frame: 24 weeks ]Proportion of subjects with platelet count ≥50×10^9/L in ≥ 75% of the total number of tests
- Measurements of platelet count at each visit time point [ Time Frame: 24 weeks ]Platelet count at each visit time point
- Emergency treatment [ Time Frame: 24 weeks ]Percentage of subjects who received emergency treatment
- Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale [ Time Frame: 24 weeks ]Changes of the subjects' numbers in WHO bleeding score after Anti-CD38 antibody treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
- Occurrence of thrombosis [ Time Frame: 24 weeks ]Assessment of the occurrence of thrombosis during the study period
- Measurements of antiphospholipid antibody [ Time Frame: 24 weeks ]Measurements of the level of antiphospholipid antibody during the study period
- platelet count ≥50×10^9/L at least once [ Time Frame: 8 weeks ]Percentage of subjects with a platelet count ≥50×109/L at least once 8 weeks after the first dose
- platelet count ≥30×10^9/L and at least 2-fold from baseline on at least one occasion [ Time Frame: 8 weeks ]The percentage of subjects with a platelet count ≥30×10^9/L and at least 2-fold from baseline 8 weeks after the first dose on at least one occasion
- Measurements of various subsets of immunocompetent cells [ Time Frame: 24 weeks ]To assess the changes of the percentage of B cell subsets,regulatory B cells(Breg),regulatory T cells (Treg),supressor T cells(Ts),monocyte subcets, helper T cells(Th)subsets and the functionally-polarized CD4+ T cell subsets, etc. in peripheral blood mononuclear cells(PBMCs)before and after anti-CD38 antibody therapy, and to compare with the healthy controls.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 and above, male or female.
- Conform to the diagnostic criteria of antiphospholipid syndrome (APS).
- Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab, CSA or CTX etc., or those who cannot chose other second-line therapy.
- Platelet count of <30 X 10^9/L.
- With normal hepatic and renal functions.
- ECOG physical state score ≤ 2 points.
- Cardiac function of the New York Society of Cardiac Function ≤ 2.
- Signed and dated written informed consent
Exclusion Criteria:
- Received any treatment of anti-CD38 antibody drug
- Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;
- HIV positive;
- Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;
- Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;
- At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;
- Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;
- Those who have received allogeneic stem cell transplantation or organ transplantation in the past;
- Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;
- Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;
- Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);
- Patients with septicemia or other irregular severe bleeding;
- Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05983952
Contact: Yunfei Chen, MD | +8618502220788 | chenyunfei@ihcams.ac.cn |
China, Tianjin | |
Chinese Academy of Medical Science and Blood Disease Hospital | Recruiting |
Tianjin, Tianjin, China, 300020 | |
Contact: Yunfei Chen, MD +86-22-23909009 chenyunfei@ihcams.ac.cn |
Principal Investigator: | Lei Zhang, MD | Chinese Academy of Medical Science and Blood Disease Hospital |
Responsible Party: | Zhang Lei, MD, vice Director of Thrombosis and Hemostasis Center, Institute of Hematology & Blood Diseases Hospital, China |
ClinicalTrials.gov Identifier: | NCT05983952 |
Other Study ID Numbers: |
03CD38APS |
First Posted: | August 9, 2023 Key Record Dates |
Last Update Posted: | August 14, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | 12 months to 36 months after study completion |
Access Criteria: | Upon request to PI |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Thrombocytopenia Antiphospholipid Syndrome Syndrome Disease Pathologic Processes Blood Platelet Disorders Hematologic Diseases |
Cytopenia Autoimmune Diseases Immune System Diseases Antibodies Immunologic Factors Physiological Effects of Drugs |