NCT05858684 is a EARLY_PHASE1 clinical trial of GC012F injection in CAR-T Cell Therapy, sponsored by RenJi Hospital.

Who is sponsoring NCT05858684?

NCT05858684 is sponsored by RenJi Hospital.

What drugs are being tested in NCT05858684?

Interventions in NCT05858684: GC012F injection.

What condition does NCT05858684 study?

NCT05858684 studies CAR-T Cell Therapy.

Is NCT05858684 still recruiting?

NCT05858684 is currently status unknown. Last updated 15 May 2023.

Last reviewed 2023-05-15 · How we verify

NCT05858684

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients

Status unknown EARLY_PHASE1 Last updated 15 May 2023

What this trial tests

EARLY_PHASE1 trial testing GC012F injection in CAR-T Cell Therapy in 18 participants. Status unknown.

Timeline

11 May 2023

Primary endpoint
10 November 2023

10 May 2025

Quick facts

Lead sponsor	RenJi Hospital
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	11 May 2023
Primary completion	10 November 2023
Estimated completion	10 May 2025
Sites	1 location across China

Drugs / interventions tested

GC012F injection — full drug profile →

Conditions studied

CAR-T Cell Therapy — all drugs for CAR-T Cell Therapy →

Sponsor

RenJi Hospital

Who can join

Adults 18 to 70, any sex, with CAR-T Cell Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Chimeric antigen receptor T cell therapy for autoimmune disease.
Chung JB, Brudno JN, Borie D, Kochenderfer JN. · · 2024 · cited 85× · PMID 38831163 · DOI 10.1038/s41577-024-01035-3
CAR T cells for treating autoimmune diseases.
Blache U, Tretbar S, Koehl U, Mougiakakos D, et al · · 2023 · cited 54× · PMID 37996128 · DOI 10.1136/rmdopen-2022-002907
CAR T-cell therapy for systemic lupus erythematosus: current status and future perspectives.
Zhou J, Lei B, Shi F, Luo X, et al · · 2024 · cited 26× · PMID 39749335 · DOI 10.3389/fimmu.2024.1476859
Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806
Cutting-edge approaches to B-cell depletion in autoimmune diseases.
Robinson WH, Fiorentino D, Chung L, Moreland LW, et al · · 2024 · cited 24× · PMID 39445025 · DOI 10.3389/fimmu.2024.1454747
Application of novel CAR technologies to improve treatment of autoimmune disease.
Cheever A, Kang CC, O'Neill KL, Weber KS. · · 2024 · cited 18× · PMID 39445021 · DOI 10.3389/fimmu.2024.1465191
Current cell therapies for systemic lupus erythematosus.
Dao LTM, Vu TT, Nguyen QT, Hoang VT, et al · · 2024 · cited 16× · PMID 38920310 · DOI 10.1093/stcltm/szae044
Current advancements in cellular immunotherapy for autoimmune disease.
Berry CT, Frazee CS, Herman PJ, Chen S, et al · · 2025 · cited 15× · PMID 39821376 · DOI 10.1007/s00281-024-01034-5

Verify or expand the search:

Other trials of GC012F injection

Trials testing the same drug.

NCT07072884 — GC012F in Patients With Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
NCT07058298 — GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103) · EARLY_PHASE1 · recruiting
NCT06759948 — An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis · Phase 1 · not yet recruiting
NCT06419166 — An Exploratory Clinical Study of GC012F Injection for Refractory gMG · EARLY_PHASE1 · withdrawn
NCT05846347 — Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus · Phase 1 · unknown

Other recruiting trials for CAR-T Cell Therapy

Currently open trials in the same condition.

NCT07246304 — TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC · EARLY_PHASE1 · recruiting
NCT07269587 — A Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19 · active not recruiting
NCT07198867 — A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT07120633 — Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL · NA · recruiting
NCT06842589 — Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cell Therapy in Patients With MDR-SRNS · Phase 1 · recruiting

Other RenJi Hospital trials

Trials by the same sponsor.

NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
NCT07537725 — EEG-TMS for Postoperative Delirium After Cardiac Surgery · NA · not yet recruiting
NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
NCT07343076 — Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE · NA · not yet recruiting
NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05858684 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by RenJi Hospital
Last refreshed: 15 May 2023

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/NCT05858684.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing