---
title: Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases
nct_id: NCT06871644
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06871644.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06871644"
ct_last_update_post_date: 2025-03-12
last_seen_at: "2026-05-12T07:22:31.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases

**Official Title:** CD7CAR-T Cell Therapy As a Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study

**NCT ID:** [NCT06871644](https://clinicaltrials.gov/study/NCT06871644)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- **Conditions:** Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
- **Start Date:** 2025-03-18
- **Completion Date:** 2027-03-31
- **CT.gov Last Update:** 2025-03-12

## Brief Summary

The primary objective was to evaluate the safety of CD7 CAR-T cells for the treatment of subjects with relapsed/refractory AID. CD7 CAR-T cells were infused in a single infusion in subjects who were screened after signing an informed consent form and undergoing single nucleus cell collection and pretreatment, and blood was collected before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations.

## Detailed Description

Subjects who meet the inclusion/exclusion criteria will be entered into 3 groups in sequential order for a single dose. The dose-escalation study utilizes a "3+3" design, i.e., 3-6 subjects in each group will complete a single dose.

After the last subject in each dose group completes a dose-limiting toxicity (DLT) assessment window of 28 days after the single dose, enrollment in the next dose group can begin.

When 1 DLT occurs in 3 subjects in a dose group, 3 additional subjects are required in the same dose group (up to 6 subjects in that dose group have completed DLT assessment): if no DLT occurs in the 3 additional subjects, continue the dose escalation; if 1 of the 3 additional subjects develops a DLT, stop the dose escalation; if \>1 of the 3 additional subjects DLT occurs, the dose escalation is stopped and a one-dose reduction is required to continue enrolling 3 more subjects for DLT assessment.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

\- Diagnosed relapsing/refractory systemic sclerosis that has failed treatment with at least two immunosuppressive and/or biologic agents.

Bone marrow and coagulation function, liver and kidney function, cardiopulmonary function are satisfied No serious mental disorders

Exclusion Criteria:

\- Malignancy other than AID disease within 5 years prior to screening Hepatitis B surface antigen (HBsAg) positive, AIDS, syphilis and other virus positive persons Severe heart disease
```

## Arms

- **T cell injection targeting CD7 chimeric antigen receptor** (EXPERIMENTAL) — CD7 CAR-T cell therapy Subjects meeting the inclusion/exclusion criteria will be entered into the 0.25×108, 1×108, and 2×108 CAR-T groups in sequential order, and will be administered once

## Interventions

- **T cell injection targeting CD7 chimeric antigen receptor** (BIOLOGICAL) — Subjects who sign the informed consent form and meet the inclusion/exclusion criteria will be entered into the 0.25×108, 1×108 and 2×108 CAR-T groups, in order of priority, and will be administered 1 dose of

## Primary Outcomes

- **adverse events** _(time frame: About 1 year)_ — Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

## Secondary Outcomes

- **（Cmax）** _(time frame: About 1 year)_
- **（Tmax）** _(time frame: About 1 year)_
- **AUC0-28d** _(time frame: About 28 days)_
- **AUC0-90d** _(time frame: About 90 days)_
- **Disease remission rate** _(time frame: About 90 days)_

## Locations (1)

- PersonGen.Anke Cellular Therapeutice Co. Ltd, Hefei, Anhui, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — 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)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.persongen.anke cellular therapeutice co. ltd|hefei|anhui|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06871644*  
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