Allogeneic CD7-CAR-T (RD13-02)
What it is
An early dose-escalation study of donor-derived CD7-targeted CAR-T cells in stage 2 or 3 T1D. Nine participants are planned; no outcomes are posted.
Editorial review: . What was checked and what remains uncertain.
Latest dated source in the citation list: 2026-04-14. This is the source’s date, not a new review of every claim.
Trial status, labels and access can change between reviews.
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Beta-cell preservation: No clinical preservation result is posted for this programme.[1]
- Important harms and treatment burden
- Safety: The study is designed to assess safety; no programme-specific adverse-event results are posted.[1]
- Approval and country access
- An early dose-escalation study of donor-derived CD7-targeted CAR-T cells in stage 2 or 3 T1D. Nine participants are planned; no outcomes are posted.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Lasting immune control or insulin independence has not been demonstrated in the registry.[1]
Research status alone does not establish approval, clinical benefit or local availability.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 10 × 30 + 8 × 20 + 20 × 20 + 25 × 10 + 15 × 20 = 1410; divide by total weight 100. Unrounded weighted result: 14.1.
Lasting immune control or insulin independence has not been demonstrated in the registry.[1]
The study is designed to assess safety; no programme-specific adverse-event results are posted.[1]
The study selects ages 18–40 with stage 2 or 3 T1D, autoantibodies and residual C-peptide.[1]
Evidence is limited to an early registered study; planned enrolment is not a treated or analyzed cohort.[1]
The full picture
A distinct immune-cell intervention
Shanghai Zhongshan Hospital's early Phase 1 study tests RD13-02, an allogeneic (donor-derived) CD7-targeted CAR-T product. It is a single-arm infusion study with dose escalation and explicit toxicity stopping rules, not beta-cell replacement.1
The registry lists recruiting, nine participants planned and primary completion estimated for December 2027. No results are posted. Stage 2 and stage 3 are protocol eligibility groups; this does not establish preventive efficacy in stage 2, reversal in stage 3, or an accepted risk-benefit balance for either population. Current site access needs confirmation.
Neither a maximum tolerated dose nor a durable clinical benefit can be inferred from the design. The small uncontrolled sample will also limit interpretation of any future efficacy signal.
Sources
- [1]NCT07528105 — study record · registry · 2026-04-14 — Registry update date; retrieved 16 September 2026. Registry registration is not proof of clinical benefit.