UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age10+
SponsorThe Second Hospital of Anhui Medical University
About this trial
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in AIHA who have failed ≥ 3 lines of therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age ≥ 10 years, regardless of sex;
2. Flow cytometry-confirmed CD19 or BCMA positivity on B cells in peripheral blood or bone marrow;
3. 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)";
4. 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;
Disqualifiers
1. Subjects with a history of severe drug allergies or allergic tendencies;
2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
3. History of recurrent infections (e.g., ≥3 episodes of active infection requiring medical intervention within 6 months prior to enrollment);
4. History of cytomegalovirus (CMV), Epstein-Barr virus (EBV), or fungal infections within 3 months prior to screening, or history of recurrent CMV, EBV, or fungal infections;
Trial design
Design model
Single group
Treatments tested in this trial
QT-219C Cell Injection
Biological/VaccineA single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: QT-219C Cell InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose-Limiting Toxicities (DLTs)
The number, frequency, and severity of DLTs experienced by subjects after the first infusion of QT-219C. DLTs are defined by NCI-CTCAE 5.0 and ASTCT consensus for CRS and neurotoxicity
Time frame
Day 0 to Day 28 post-infusion2
Incidence of Adverse Events (AEs)
Evaluation of the number, frequency, and severity of all adverse events, including Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs).
Time frame
Up to 12 Months After UCAR T-cell Infusion3
Clinical response of AIHA who have failed ≥ 3 lines of therapy
Rates of CR, CRi, PR, ORR
Time frame
Up to 24 Weeks After UCAR T-cell InfusionSecondary outcomes
1
Cmax of CAR-T cells [PK parameter]
The peak plasma concentration (Cmax) of amplified UCAR-T cells in peripheral blood after infusion
Time frame
Within 28 Days After UCAR T-cell Infusion2
Tmax of CAR-T cells [PK parameter]
The time of amplified UCAR-T cells in peripheral blood to reach the maximum concentration (Tmax).
Time frame
Within 28 Days After UCAR T-cell Infusion3
AUC 0-28d of UCAR-T cells [PK parameter]
The area under the plasma concentration-time curve from 0 to 28 days after infusion (AUC0-28d)
Time frame
Within 28 Days After UCAR T-cell InfusionSponsors and contacts
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Source ClinicalTrials.gov