AIHA - Warm Autoimmune Hemolytic AnemiaEarly Phase 1NCT07530380
UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
A Early Phase 1 study testing QT-219C Cell Injection in people with AIHA - Warm Autoimmune Hemolytic Anemia and UCART, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- AIHA - Warm Autoimmune Hemolytic Anemia, UCART
- What is being tested?
- QT-219C Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to 31 Dec 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
- 5. Functional requirements for major organs are as follows:
- The bone marrow function needs to meet: a Neutrophil count ≥ 1.0
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- × 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).
- 6. ECOG ≤ 2;
- 7. 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;
- 8. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- 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;
- 5. Receipt of any vaccination within 12 weeks prior to enrollment, or participation in a vaccine clinical trial within 12 weeks prior to enrollment;
- 6. Subjects with insufficient cardiac function;
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- 7. Moderate to severe congestive heart failure (New York Heart Association [NYHA] Class III-IV);
- 8. Subjects with congenital immunoglobulin deficiencies;
- 9. 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);
- 10. 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;
- 11. History of organ transplantation, including but not limited to bone marrow or hematopoietic stem cell transplantation;
- 12. Severe, progressive, uncontrolled disease of the cardiovascular, cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematologic, endocrine, or nervous system;
- 13.Psychiatric disorder or severe cognitive impairment;
- 14. Pregnant women or women planning to conceive
- 15. Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Anhui Medical University
Hefei
Zhimin Zhai, PhD, +86-0551-65997091, zzzm889@163.com
About this study
Official title: A Clinical Study of CD19/BCMA-Targeted Universal Allogeneic CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Hemolytic Anima: Evaluating Safety and Preliminary Efficacy
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
Read the detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in autoimmune hemolytic anemia who have failed ≥ 3 lines of therapy. Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when participants finish the visit 12 weeks after CAR T-cell infusion.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, UCART
- Being tested
- QT-219C Cell Injection
- Keywords
- AIHA, UCART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QT-219C Cell InjectionBiological
A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells.
| Study group | Role | What they receive |
|---|---|---|
| QT-219C Cell Injection | Experimental | Universal allogeneic anti-CD19/BCMA CAR T-cells Receives: Biological: QT-219C Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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
Measured: Up to 24 Weeks After UCAR T-cell Infusion
Secondary outcomes (3)
Cmax of CAR-T cells [PK parameter]
The peak plasma concentration (Cmax) of amplified UCAR-T cells in peripheral blood after infusion
Measured: Within 28 Days After UCAR T-cell Infusion
Tmax of CAR-T cells [PK parameter]
The time of amplified UCAR-T cells in peripheral blood to reach the maximum concentration (Tmax).
Measured: Within 28 Days After UCAR T-cell Infusion
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)
Measured: Within 28 Days After UCAR T-cell Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startApr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIHA - Warm Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Zhai, The Second Hospital of Anhui Medical University
- Investigators
- Zhai, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530380
- Sponsor's protocol ID
- QH-AY-02
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of CD19/BCMA-Targeted Universal Allogeneic CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Hemolytic Anima: Evaluating Safety and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT07530380
- Acronym / sponsor ID
- QH-AY-02
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, UCART
- Keywords
- AIHA, UCART
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in autoimmune hemolytic anemia who have failed ≥ 3 lines of therapy. Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when participants finish the visit 12 weeks after CAR T-cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QT-219C Cell Injection | Experimental | Biological: QT-219C Cell InjectionUniversal allogeneic anti-CD19/BCMA CAR T-cells |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- 5. Functional requirements for major organs are as follows:
Key exclusion criteria (15 listed)
- 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;
- 5. Receipt of any vaccination within 12 weeks prior to enrollment, or participation in a vaccine clinical trial within 12 weeks prior to enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QT-219C Cell InjectionA single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells. | Biological | QT-219C Cell Injection |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Day 0 to Day 28 post-infusion
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
Incidence of Adverse Events (AEs)
Time frame: Up to 12 Months After UCAR T-cell Infusion
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).
Clinical response of AIHA who have failed ≥ 3 lines of therapy
Time frame: Up to 24 Weeks After UCAR T-cell Infusion
Rates of CR, CRi, PR, ORR
3 secondary outcomes
Cmax of CAR-T cells [PK parameter]
Time frame: Within 28 Days After UCAR T-cell Infusion
Tmax of CAR-T cells [PK parameter]
Time frame: Within 28 Days After UCAR T-cell Infusion
AUC 0-28d of UCAR-T cells [PK parameter]
Time frame: Within 28 Days After UCAR T-cell Infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhai principal investigator
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing QT-219C Cell Injection in people with AIHA - Warm Autoimmune Hemolytic Anemia and UCART, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Zhai, PhD (+86-0551-65997091, zzzm889@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Day 0 to Day 28 post-infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.