UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia

NCT07530380 | Recruiting Early Phase 1 DMC

• 1 other identifier: QH-AY-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AIHA - Warm Autoimmune Hemolytic Anemia; UCART

Keywords

AIHA; UCART

Outcome Measures

Primary Outcomes (3)

• 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

  Day 0 to Day 28 post-infusion

• 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).

  Up to 12 Months After UCAR T-cell Infusion

• Clinical response of AIHA who have failed ≥ 3 lines of therapy

  Rates of CR, CRi, PR, ORR

  Up to 24 Weeks After UCAR T-cell Infusion

Secondary Outcomes (3)

• Cmax of CAR-T cells [PK parameter]

  Within 28 Days After UCAR T-cell Infusion

• Tmax of CAR-T cells [PK parameter]

  Within 28 Days After UCAR T-cell Infusion

• AUC 0-28d of UCAR-T cells [PK parameter]

  Within 28 Days After UCAR T-cell Infusion

Study Arms (1)

QT-219C Cell Injection

EXPERIMENTAL

Universal allogeneic anti-CD19/BCMA CAR T-cells

Biological: QT-219C Cell Injection

Interventions

QT-219C Cell Injection BIOLOGICAL

A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells.

QT-219C Cell Injection

Eligibility Criteria

• Age: 10 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 10 years, regardless of sex;
• \. Flow cytometry-confirmed CD19 or BCMA positivity on B cells in peripheral blood or bone marrow;
• \. 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 ≥ 1.0
• × 10 \^ 9/L; b. Platelets ≥ 30 × 10 \^ 9/L.
• Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN# Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN).
• Renal function: creatinine clearance rate (CrCl) ≥ 30 ml/min (Cockcroft/Gault formula, excluding acute CrCl decline caused by the disease itself).
• \. ECOG ≤ 2;
• \. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating;
• \. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• \. 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;
• \. History of recurrent infections (e.g., ≥3 episodes of active infection requiring medical intervention within 6 months prior to enrollment);
• \. 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;
• \. Receipt of any vaccination within 12 weeks prior to enrollment, or participation in a vaccine clinical trial within 12 weeks prior to enrollment;
• \. Subjects with insufficient cardiac function;
• \. Moderate to severe congestive heart failure (New York Heart Association \[NYHA\] Class III-IV);
• \. Subjects with congenital immunoglobulin deficiencies;
• \. History of malignancy within the past 5 years (except for non-melanoma skin cancer, completely resected Stage I tumor with low risk of recurrence, treated clinically localized prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesion on smear, and stable papillary or follicular thyroid cancer);
• \. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; 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;
• \. History of organ transplantation, including but not limited to bone marrow or hematopoietic stem cell transplantation;
• \. Severe, progressive, uncontrolled disease of the cardiovascular, cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematologic, endocrine, or nervous system;
• Psychiatric disorder or severe cognitive impairment;
• \. Pregnant women or women planning to conceive

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, China

RECRUITING

Study Officials

• Zhai

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Zhai, PhD

CONTACT

+86-0551-65997091; zzzm889@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Hematology Department

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)