Health TrialsbyHealthPanel

Anti-CD38 Antibody Treating APS With Thrombocytopenia

ConditionsAntiphospholipid SyndromeThrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To evaluate the safety and efficacy of anti-CD38 antibody in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Anti-CD38 antibody Injection

    Drug

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Intervention（Anti-CD38 antibody）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the efficacy after anti-CD38 antibody treatment within 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

Time frame
8 weeks
2

Safety of anti-CD38 antibody

Incidence, severity, and relationship of treatment emergent adverse events after anti-CD38 antibody treatment

Time frame
24 weeks

Secondary outcomes

1

Response rate of treatment

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）.

Time frame
12 weeks
2

Duration from treatment initiation to platelet count ≥50×10^9/L

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

Time frame
12 weeks
3

Duration of platelet response

The longest duration for which the subject sustained a platelet count ≥50×109/L

Time frame
24 weeks
4

platelet count ≥50×10^9/L ≥75% tests

Proportion of subjects with platelet count ≥50×10\^9/L in ≥ 75% of the total number of tests

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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