---
title: A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
nct_id: NCT05085444
overall_status: UNKNOWN
phase: EARLY_PHASE1
sponsor: Zhejiang University
study_type: INTERVENTIONAL
primary_condition: Scleroderma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05085444.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05085444"
ct_last_update_post_date: 2021-10-20
last_seen_at: "2026-05-12T07:21:49.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

**NCT ID:** [NCT05085444](https://clinicaltrials.gov/study/NCT05085444)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** Zhejiang University
- **Collaborators:** Yake Biotechnology Ltd.
- **Conditions:** Scleroderma, Autoimmune Diseases
- **Start Date:** 2021-10-08
- **Completion Date:** 2024-10-08
- **CT.gov Last Update:** 2021-10-20

## Brief Summary

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

## Detailed Description

Autoimmune diseases only show local pathological damage, but more often systemic lesions. If not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. Studies have shown that B cells can present their own antigens to autoimmune T cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. In recent years, it has become a major research focus to deplete B cells in patients or inhibit B cell function. This research focuses on CAR-T cells killing B cells. This fully reflects the application prospects of CAR-T cells in autoimmune diseases.

Based on the current research progress, our center intends to conduct research on the safety and effectiveness of CD19/BCMA CAR-T cells in the treatment of refractory scleroderma

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Scleroderma with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment
2. Estimated survival time\> 12 weeks;
3. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
4. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

* Subjects with any of the following exclusion criteria were not eligible for this trial:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
  8. Other uncontrolled diseases that were not suitable for this trial;
  9. Patients with HIV infection;
  10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
  11. Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
  12. Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.
```

## Arms

- **Treatment of Scleroderma** (EXPERIMENTAL) — Experimental：Administration of CD19/BCMA CAR T-cells A dose levels of 1-4\*10E6/kg are administrated for each subject.

## Interventions

- **Assigned Interventions CD19/BCMA CAR T-cells** (BIOLOGICAL) — Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection

## Primary Outcomes

- **Dose-limiting toxicity (DLT)** _(time frame: Baseline up to 28 days after CD19/BCMA CAR T-cells infusion)_ — Adverse events assessed according to NCI-CTCAE v5.0 criteria
- **Incidence of treatment-emergent adverse events (TEAEs)** _(time frame: Up to 90 days after CD19/BCMA CAR T-cells infusion)_ — Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

## Secondary Outcomes

- **Concentration of CAR-T cells** _(time frame: From admission to the end of the follow-up, up to 2 years)_
- **Objective Response Rate, ORR** _(time frame: In 3 months of CD19/BCMA CAR-T cell infusion)_
- **Disease control rate, DCR** _(time frame: From Day 28 CD19/BCMA CAR-T infusion up to 2 years)_
- **Duration of remission, DOR** _(time frame: 24 months post CD19/BCMA CAR-T cells infusion)_
- **Progression-free survival, PFS** _(time frame: 24 months post CD19/BCMA CAR-Tcells infusion)_
- **Overall survival, OS** _(time frame: From CD19/BCMA CAR-T infusion to death，up to 2 years)_

## Locations (1)

- The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the first affiliated hospital, college of medicine, zhejiang university|hangzhou|zhejiang|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05085444.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05085444*  
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