CTA311 / Nanjing Bioheng Biotech, Wuhan Union Hospital - LARVOL DELTA

BHCT-RD06-04-01: Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P=N/A | N=12 | Suspended | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting ➔ Suspended | Trial primary completion date: Mar 2025 ➔ Dec 2026

Trial primary completion date • Trial suspension • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

BHCT-RD06-04-04: A Study of RD06-04 in Patients With Active Autoimmune Diseases (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Nanjing Bioheng Biotech Co., Ltd. | N=18 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Neuromyelitis Optica Spectrum Disorder • Vasculitis • LRP4

BHCT-RD06-04-05: Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases (clinicaltrials.gov) - P1 | N=12 | Suspended | Sponsor: Nanjing Bioheng Biotech Co., Ltd. | Recruiting ➔ Suspended

Trial suspension • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

CTA311, a universal anti-CD19 CAR t-cell therapy with improved persistence for patients with CD19+ relapsed/ refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL) (ASH 2025) - "All pts received a lymphodepletion regimen consisting of fludarabine(30mg/m2/day) and cyclophosphamide (500mg/ m2/day) for 3 consecutive days (day -5 to -3) before CAR-Tinfusion (day 0). CTA311 demonstrates robust persistence, achieving a 100% MRDneg CR/CRi, at doseslower than approved for autologous CAR-T, and mDOR not yet reached, while maintaining a manageablesafety profile under standard lymphodepletion. Additional studies are planned to further confirm theseinitial findings."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia

A poster (Abstract #5920) emphasizing similar scalability of CTA311, highlighted results suggesting the therapeutic candidate has strong efficacy and favorable safety for R/R B-ALL patients. (GlobeNewswire) - "CTA311 was well tolerated with no dose-limiting toxicities, neurotoxicity, or GvHD; cytokine release syndrome occurred in 54.5% (Grade 1–2 only). Robust CAR-T expansion and persistence were observed, with B-cell depletion aligning with expansion. Among 9 evaluable patients, 78% achieved CR/CRi/CRh, and 86% were MRD-negative. Median duration of remission was not reached at 12.8 months follow-up, with the longest ongoing remission at 16.4 months."

P1 data • B Acute Lymphoblastic Leukemia • Lymphoblastic Lymphoma

Imviva Biotech Announces Seven Presentations Highlighting its ANSWER Allogeneic CAR-T Platform at the 67th American Society of Hematology Annual Meeting (GlobeNewswire) - "The company will present the latest clinical data for CTD402, its investigational CD7 allogeneic CAR-T cell therapy, and CTA311, a universal anti-CD19 CAR-T cell therapy in development for patients with T-ALL/LBL, AML, B-ALL and severe aplastic anemia, and relapsed/ refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), respectively. An oral presentation on CTD402 in relapsed/refractory T-ALL/LBL has been selected as a conference highlight..."

Clinical data • Acute Myelogenous Leukemia • Aplastic Anemia • B Acute Lymphoblastic Leukemia • Lymphoblastic Lymphoma • T-cell Acute Lymphoblastic Lymphoma

Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Peking University People's Hospital

New P1 trial • ANCA Vasculitis • Myositis • Vasculitis

Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd.

CAR T-Cell Therapy • New P1 trial • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Clinical Study on Targeted CD19 CAR-T Therapy for Autoimmune Diseases (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd.

New P1 trial • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

A Study of RD06-04 in Patients With Active Autoimmune Diseases (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd.

CAR T-Cell Therapy • New P1 trial • ANCA Vasculitis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Neuromyelitis Optica Spectrum Disorder • Systemic Lupus Erythematosus • Vasculitis

Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P=N/A | N=12 | Recruiting | Sponsor: Wuhan Union Hospital, China

CAR T-Cell Therapy • New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus