Allogeneic CD7-targeted CAR-T for T1D
What this study tests
Very early (registry "Early Phase 1") single-site study at Zhongshan Hospital, Shanghai, of an off-the-shelf CD7-targeted CAR-T cell product (RD13-02) in 9 adults with stage 2 or stage 3 type 1 diabetes, measuring safety, cellular kinetics and C-peptide changes.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-04-14.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Ages 18-40 with stage 2 or stage 3 T1D; at least one islet autoantibody (people with two or more are prioritised for enrolment); peak C-peptide >0.2 nmol/L on a mixed-meal tolerance test, or fasting C-peptide >0.1 nmol/L. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Planned enrolment is 9 participants; the study started in April 2026, with primary completion estimated for December 2027.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Dose-limiting toxicities and adverse events
- Change from baseline in 4-hour MMTT C-peptide AUC
The full picture
What is being tested, and why it matters
In type 1 diabetes the immune system's own T cells destroy the insulin-making beta cells. CAR-T therapy re-engineers immune cells to hunt a chosen target; here the target is CD7, a marker carried by T cells and NK cells. The idea is to use CAR-T cells to strip out the immune cells doing the damage — a deep immune reset — in the hope that whatever beta-cell function remains survives.
Two things make this study unusual. First, the cells are allogeneic — made from a donor rather than from the patient, so they could in principle be an off-the-shelf product rather than a bespoke one. The product is coded RD13-02.1 Second, this is a very aggressive tool aimed at an autoimmune disease rather than a cancer, so safety is the whole question at this stage.
Who it is for
Adults aged 18-40 with stage 2 or stage 3 type 1 diabetes (by the ADA 2024 staging criteria) — that is, people whose autoimmunity has already progressed to abnormal glucose levels or to clinical diagnosis. Entrants need at least one islet autoantibody, and those with two or more are prioritised. Crucially, they must still have measurable insulin production: a peak C-peptide above 0.2 nmol/L on a mixed-meal tolerance test, or a fasting C-peptide above 0.1 nmol/L.1 There has to be something left to protect.
How the study is designed
NCT07528105 is registered on ClinicalTrials.gov as Early Phase 1 — the earliest possible stage of human testing, a rung below a conventional Phase 1. (We file it under Phase 1 because our categories have no separate early-phase bucket.) It is a single-site study at Zhongshan Hospital, Fudan University, in Shanghai, with a planned enrolment of just 9 participants. It began in April 2026 and lists an estimated primary completion of December 2027.1 The primary measures are safety — dose-limiting toxicities and adverse events — alongside change in C-peptide production.1
What it means and what is next
No results have been posted.1 Nine participants (registry-estimated enrolment) at one hospital makes this an Early Phase 1 safety probe as registered, not a test of whether this works. Treat it as a signal that CAR-T-based immune reset is now being tried in type 1 diabetes, not as evidence that it helps. The questions that matter — does wiping out CD7-positive cells preserve beta-cell function, and at what cost in infection risk and toxicity — will not be answered by a study this size. The registry-estimated primary completion is December 2027, so read-outs are unlikely before late 2027.
Sources
- [1]NCT07528105: Allogeneic CD7-targeted CAR-T for T1D · Trial registry — Live-checked 27 August 2026: status recruiting, phase Early Phase 1, enrolment 9, ages 18-40, start April 2026, primary completion December 2027, no results posted.
NCT07528105: Allogeneic CD7-targeted CAR-T for T1D — ClinicalTrials.gov (live-checked 27 August 2026).