A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNuwacell Biotechnologies Co., Ltd.

About this trial

Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age>18 years and <70 years old (including threshold), gender not limited;

Grade II to IV gastrointestinal involvement acute graft-versus-host disease(aGVHD);

Subjects with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD);

Failed to second-line aGVHD treatment;

Disqualifiers

Subjects have lung disease, and investigators have determined that they are not suitable for the study;

Subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome;

Subjects with signs/symptoms of chronic GVHD;

Subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (CMV) enteritis, transplant related thrombotic microvascular disease (TA-TMA), or digestive tract infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • NCR102 injection

    Biological/Vaccine

    Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: NCR102 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Event(AE) or Serious Adverse Event(SAE)

Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0

Time frame
100 days after first administration of NCR102 injection

Secondary outcomes

1

ORR at Day 28

Overall Response Rate(ORR) at Day 28

Time frame
28 days after first dose administration
2

CRR at Day 28

Complete Response Rate(CRR) at Day 28

Time frame
28 days after first dose administration
3

ORR at Day 56

Overall Response Rate(ORR) at Day 56

Time frame
56 days after first dose administration

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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