OncoMatch/Clinical Trials/NCT07337785
CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
Is NCT07337785 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including CD19/BCMA-targeted CAR-T cells and Lymphodepleting Conditioning for relapsing or refractory multiple sclerosis (ms).
Treatment: CD19/BCMA-targeted CAR-T cells · Lymphodepleting Conditioning — This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders. In this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data. For each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: high-efficacy disease-modifying therapy (anti-CD20 monoclonal antibodies, Ocrelizumab, lymphocyte-depleting therapies, Alemtuzumab, Cladribine, α4 integrin blockers, Natalizumab) — MS
Having received high-efficacy disease-modifying therapy (DMT) for at least 6 months, with the occurrence of any of the following conditions during the treatment period: relapse or EDSS progression
Must have received: immunosuppressant or biologic agent (azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, cyclophosphamide, complement C5 inhibitors, FcRn blockers) — MG
Having received at least one of the following treatments prior to screening, with relevant medical documentation provided: Immunosuppressants (including but not limited to azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, cyclophosphamide, etc.) or Biologic agents (including but not limited to complement C5 inhibitors, FcRn blockers, etc.)
Must have received: IVIG, oral prednisone, plasma exchange, or FcRn blocker (IVIG, oral prednisone, plasma exchange, FcRn blockers, Efgartigimod) — CIDP
Having received any of the following treatments for at least 3 months, with either the INCAT score improves by < 2 points compared to the baseline, or the treatment discontinuation due to adverse reactions: IVIG, oral prednisone, plasma exchange, FcRn blockers (e.g., Efgartigimod)
Must have received: glucocorticoid and at least one immunosuppressant/immunomodulator (including CD20 monoclonal antibody) (glucocorticoids, CD20 monoclonal antibody) — AE
Poor symptom control or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant/immunomodulator (including CD20 monoclonal antibody)
Cannot have received: allogeneic bone marrow or stem cell transplantation
History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart, liver), or planned future transplantation of such organs/cells.
Cannot have received: solid organ transplantation (kidney, lung, heart, liver)
History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart, liver), or planned future transplantation of such organs/cells.
Lab requirements
Blood counts
Neutrophil count ≥ 1 × 10⁹/L; hemoglobin ≥ 60 g/L; platelet count ≥ 20 × 10⁹/L; lymphocyte count > 0.3 × 10⁹/L
Kidney function
Serum creatinine ≤ 1.5 × ULN OR creatinine clearance rate ≥ 40 ml/min
Liver function
ALT and AST ≤ 3 × ULN; TBIL ≤ 2 × ULN (except for patients with Gilbert's syndrome)
Cardiac function
LVEF ≥ 50% by echocardiography
Organ function and laboratory test requirements: Liver function: ALT and AST ≤ 3 × ULN; TBIL ≤ 2 × ULN (except for patients with Gilbert's syndrome). Renal function: Serum creatinine ≤ 1.5 × ULN OR creatinine clearance rate ≥ 40 ml/min. Complete blood count: Neutrophil count ≥ 1 × 10⁹/L; hemoglobin ≥ 60 g/L; platelet count ≥ 20 × 10⁹/L; lymphocyte count > 0.3 × 10⁹/L. Coagulation function: INR ≤ 1.5 × ULN OR PT ≤ 1.5 × ULN. Oxygen saturation (SpO₂) ≥ 92% at rest while breathing room air. Echocardiography shows LVEF ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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