Delving into the Latest Updates on RD-06-04 with Synapse

Overview

Basic Info

Drug Type

CAR-T

Synonyms

RD-06-04

Target

CD19

Action

modulators

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [8]

Active Indication

Churg-Strauss SyndromeGranulomatosis With PolyangiitisIdiopathic Inflammatory Myopathies+ [9]

Inactive Indication-

Originator Organization

Nanjing Bioheng Biotech Co., Ltd.

Active Organization

Nanjing Bioheng Biotech Co., Ltd.

Wuhan Xiehe Hospital Tower

Inactive Organization-

License Organization-

Drug Highest PhaseEarly Phase 1

First Approval Date-

Regulation-

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This is an open-label, investigator-initiated clinical trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with refractory IIM and AAV. The study plans to enroll a total of 12 participants, with 6 cases each for IIM and AAV. Enrollment for both diseases will proceed in parallel. The dose will be 6×10^6 CAR+T cells/kg (±30%), and patients will receive a single infusion of RD06-04.

Start Date14 Jun 2025

Sponsor / Collaborator

Peking University People's Hospital

NCT06548607

/ RecruitingEarly Phase 1

Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases

This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-04 or RD06-05 in patients with active SLE, SSc, AAV, IIM and pSS.

Start Date14 Sep 2024

Sponsor / Collaborator

Nanjing Bioheng Biotech Co., Ltd.

NCT06549296

/ RecruitingEarly Phase 1

Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CAR-T Cell Injection Targeting CD19 in the Treatment of Patients With Active Autoimmune Diseases

This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS

Start Date13 Sep 2024

Sponsor / Collaborator

Nanjing Bioheng Biotech Co., Ltd.

100 Clinical Results associated with RD-06-04

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100 Translational Medicine associated with RD-06-04

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100 Patents (Medical) associated with RD-06-04

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100 Deals associated with RD-06-04

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Churg-Strauss Syndrome	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Granulomatosis With Polyangiitis	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Idiopathic Inflammatory Myopathies	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Microscopic Polyangiitis	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Multiple Sclerosis, Relapsing-Remitting	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Multiple Sclerosis, Secondary Progressive	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Myasthenia Gravis	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Neuromyelitis Optica	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Primary Sjögren's syndrome	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024
Scleroderma, Diffuse	Phase 1	China	Nanjing Bioheng Biotech Co., Ltd.	31 Aug 2024