A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

Recruiting Early Phase 1 Interventional Study
SLE LN ANCA Associated Vasculitis ANCA-Associated Glomerulonephritis Anti-GBM Disease MN SSc IIM IgA Nephropathy
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
Nanjing Bioheng Biotech Co., Ltd. · Industry
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About This Trial

An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Aged ≥18 years and ≤75 years. 3. Adequate organ function defined as: 1. Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500/μL, absolute lymphocyte count (ALC) ≥100/μL, hemoglobin (Hb) ≥80 g/L, an…
Contacts

Peng Yu

+86 18451117657

peng.yu@bioheng.com

CONTACT