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New treatment option for AIHA - Warm Autoimmune Hemolytic Anemia
Official title UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
ClinicalTrials.gov ID: NCT07530380
What this study is testing
What is QT-219C Cell Injection?
QT-219C Cell Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aiha - warm autoimmune hemolytic anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older
You may be able to join if
- 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...
- 4\. The definition of recurrent/refractory AIHA that has received at least 3 failed lines of treatment is symptomatic anemia (hemoglobin\<100g/ L)...
- 5\. Functional requirements for major organs are as follows:
You likely can't join if
- 1\. people 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...
- 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\. people with insufficient cardiac function;
See the full eligibility criteria
- 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...
- 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...
- 5\. 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).
- 6\. ECOG ≤ 2;
- 7\. Female people of childbearing potential and male people with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months...
- 8\. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
- 1\. people 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\. people with insufficient cardiac function;
- 7\. Moderate to severe congestive heart failure (New York Heart Association [NYHA] Class III-IV);
- 8\. people 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...
- 10\. people who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; people positive for hepatitis C virus (HCV) antibody and peripheral blood...
- 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\. people that the investigator believes have other reasons that make them unsuitable for inclusion in this study
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.