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Clinical Study of CHT105 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

ConditionImmune Thrombocytopenia (ITP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanjing Miracle Biotechnology Co., Ltd.

About this trial

Primary Objective: To evaluate the safety and efficacy of CHT105 Injection in subjects with relapsed/refractory autoimmune diseases.

Secondary Objective:To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CHT105 Injection.

Indication: Immune Thrombocytopenia (ITP)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤65 years (inclusive), no restriction on gender;

Positive expression of CD19/CD70 on peripheral blood B-cells as determined by flow cytometry;

Disqualifiers

Subjects with a severe history of drug allergy or allergic diathesis;

Presence or suspicion of uncontrolled or treatable fungal, bacterial, viral or other infections;

Subjects with intolerable cardiac function;

Subjects with congenital immunoglobulin deficiency;

Trial design

Design model

Single group

Treatments tested in this trial

  • CHT105

    Drug

    Single-dose administration and Multiple-dose administration, administered dose：2\*10\^8 CAR-T cells,6\*10\^8 CAR-T cells,1.8\*10\^9 CAR-T cells,3.6\*10\^9 CAR-T cells.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Types, severity, and frequency of adverse events (AEs)

Time frame
Throughout the study period, up to 52 weeks.
2

Complete response rate and partial response rate

Time frame
Week 12，Week 24

Secondary outcomes

1

Peripheral blood CAR copy number

Time frame
Day 1,Day 4,Day 7,Day 10,Day 21
2

Peripheral blood lymphocyte subsets

Time frame
Day 1,Day 4,Day 7,Day 10,Week 2,Week 3,Week 4,Week 8,Week 12,Week 24,Week 36,Week 52
3

Autoantibodies

Time frame
Day 1,Day 7,Week 2,Week 3,Week 4,Week 8,Week 12,Week 24,Week 36,Week 52

Other outcomes

Sponsors and contacts

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

Nanjing Miracle Biotechnology Co., Ltd.

Lead sponsor

The First Affiliated Hospital of Nanchang University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: