Beijing GoBroad Hospital — Biomedical Watch V2

Traitements4programmes

Essais2liés

Publications2liées

SourceDBlocale

Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
CD19-BCMA CAR-T cells infusionThis is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) and other autoimmune diseases (AID) receive CD19-BCMA CAR T cell therapy. Phase I (Dose-Escalation/Dose-De-escalation Phase)：The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, pSS-PAH and other autoimmune diseases (AID).Phase I (Dose-Escalation/Dose-De-escalation Phase)：Primary Endpoint: Safety, tolerability, and determination of the optimal biological dose (OBD) and the Phase II recommended dose (RP2D) in patients with SLE-LN, SSc, pSS-PAH, and other autoimmune diseases (AID).Phase II (Dose-Expansion Phase):Overall remission rate (ORR) \[Time Frame: 90,180 Days\]	Lupus	Phase 1/2	Thérapie cellulaire	China	À vérifier
MTM-H-001 InjectionThis is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.	Myasthénie	Non applicable		China	À vérifier
CD19-BCMA CAR-T cells infusionThis is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) and other autoimmune diseases (AID) receive CD19-BCMA CAR T cell therapy. Phase I (Dose-Escalation/Dose-De-escalation Phase)：The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, pSS-PAH and other autoimmune diseases (AID).Phase I (Dose-Escalation/Dose-De-escalation Phase)：Primary Endpoint: Safety, tolerability, and determination of the optimal biological dose (OBD) and the Phase II recommended dose (RP2D) in patients with SLE-LN, SSc, pSS-PAH, and other autoimmune diseases (AID).Phase II (Dose-Expansion Phase):Overall remission rate (ORR) \[Time Frame: 90,180 Days\]	Lupus	Phase 1/2	Thérapie cellulaire	China	À vérifier
MTM-H-001 InjectionThis is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.	Myasthénie	Non applicable		China	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
MTM-H-001 Injection	Myasthénie	Non applicable	NCT07593911	ArchAid-002 — A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases	NOT_YET_RECRUITING
CD19-BCMA CAR-T cells infusion	Lupus	Phase 1/2	NCT06947460	CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH	RECRUITING

Publications

2

Molécule	Indication / population	Titre	Journal	Date
CD19-BCMA CAR-T cells infusion		Single-cell profiling of immune reset in patients with refractory generalized myasthenia gravis receiving autologous CD19/BCMA CAR-T cell therapy.	Med (New York, N.Y.)
CD19-BCMA CAR-T cells infusion		CD19/BCMA-Targeted Chimeric Antigen Receptor-T Cell Therapy for Anti-HLA Antibody Sensitisation in Patients With Acute Leukaemia: A Pilot Clinical Study.	HLA