Not Yet RecruitingEarly Phase 1

UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Autoimmune Hemolytic Anemia

18 participantsStarted 2025-04-03

Plain-language summary

This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Autoimmune hemolytic anemia. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
✓. Patients diagnosed with AIHA, including warm antibody type, cold agglutinin disease, mixed type, and other types of AIHA, with diagnostic criteria referring to the "Chinese Adult Autoimmune Hemolytic Anemia Diagnosis and Treatment Guidelines (2023 Edition) .
✓. The definition of recurrent/refractory AIHA that has received at least 3 failed lines of treatment is symptomatic anemia (hemoglobin\<100g/L) that persists after a routine treatment cycle of at least 6 months and is still ineffective or reappears after disease remission. The definition of conventional treatment: treatment with glucocorticoids and/or rituximab, as well as any 1-2 or more of the following immunomodulatory drugs: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine A, azathioprine, danazol, bendamustine, fludarabine, bortezomib, and biologics including daratumumab, BTK inhibitors, Syk inhibitors, and complement inhibitors.
✓. Functional requirements for major organs are as follows:
✓. The bone marrow function needs to meet: a Neutrophil count ≥ 0.5× 10 \^ 9/L; b. Platelets ≥ 30 × 10 \^ 9/L.
✓. Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN.
✓. Renal function: creatinine clearance rate (CrCl) ≥ 30 ml/min (Cockcroft/Gault formula).

Exclusion criteria

✕. Subjects with a history of severe drug allergies or allergic tendencies.
✕. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
✕. Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis).
✕. Subjects with insufficient cardiac function.
✕. Subjects with congenital immunoglobulin deficiencies.
✕. History of malignancy within five years.
✕. Subjects with end-stage renal failure.
✕. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer higher than the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.

What they're measuring

The number and severity of dose-limiting toxicity (DLT) events

Timeframe: Within 28 Days After UCAR T-cell Infusion

The total number, incidence, and severity of AEs

Timeframe: Up to 90 days After UCAR T-cell Infusion

Clinical response

Timeframe: Up to 24 Months After UCAR T-cell Infusion

Trial details

NCT IDNCT06920446

SponsorZhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Relapsed / Refractory Autoimmune Hemolytic Anemia trials