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NCT07523542: SELECT-SLE
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
Phase 1, PHASE2 trial testing Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg). in REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS in 24 participants. Currently enrolling.
14 March 2027
Quick facts
| Lead sponsor | Beijing Biotech |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 2 March 2026 |
| Primary completion | 14 March 2027 |
| Estimated completion | 17 October 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg).
- Fludarabine (FLUDARABINE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS — all drugs for REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS →
- Lupus Nephritis — all drugs for Lupus Nephritis →
Sponsor
Beijing Biotech — full company profile →
Who can join
Adults 18 to 70, any sex, with REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS or Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA. Participants undergo centralized screening immunophenotyping to determine whether their disease appears B-cell-dominant (CD19-preferred) or plasma-cell-dominant (BCMA-preferred), followed by leukapheresis, lymphodepletion, and a single CAR-T infusion. The main goals are to assess safety, determine a recommended Phase 2 dose within each arm, and estimate remission rates by Week 24.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07523542
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Beijing Biotech trials
Trials by the same sponsor.
- NCT07523555 — Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies · Phase 1, PHASE2 · recruiting
- NCT07510828 — PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07510815 — Dual-Target MSLN/FAP CAR-NK Cells for Pleural and Peritoneal Mesothelioma · Phase 1, PHASE2 · recruiting
- NCT07523529 — Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07500220 — Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07523542 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Biotech
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07523542.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing