CAR-T for Autoimmune Hemolytic Anemia Patients Who Have Failed Three or More Lines of Therapy

NCT06212154 | Recruiting Phase 1

• 1 other identifier: FT400-025
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the Safety and Efficacy of ThisCART19A for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy

Conditions

Autoimmune Hemolytic Anemia; CD19 CAR-T Cell Infusion

Keywords

ThisCART19A; Autoimmune Hemolytic Anemia; Relapsed/refractory after receiving three or more lines of therapy

Outcome Measures

Primary Outcomes (2)

• The incidence and frequency of treatment-emergent adverse events

  Within 6 months

• Maximal Tolerable Dose(MTD)

  MTD is classified by the NCI CTCAE V5.0

  Up to 28 days after infusion

Secondary Outcomes (3)

• Best response rate (BOR) of each dose group

  Within 12 weeks after infusion

• Objective response rate (ORR)

  Within 4 weeks after infusion

• Time to response (TTR)

  Within 6 months

Study Arms (1)

ThisCART19A

EXPERIMENTAL

ThisCART19A comprises of allogeneic T-cells, which are genetically engineered to express chimeric antigen receptor (CAR) and targets cells expressing CD19.

Biological: ThisCART19A

Interventions

ThisCART19A BIOLOGICAL

Participants will receive ThisCART19A cell infusion after preconditioning, and they need to be closely monitored for 28 days following CAR-T cell infusion.

Also known as: Allogeneic CAR-T targeting CD19

ThisCART19A

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms.
• Male or female age ≥ 12 years.
• ECOG performance status ≤2.
• Diagnosis of warm antibody hemolytic anemia (AIHA), cold AIHA, mixed AIHA or Evans syndrome.
• Hemoglobin\<100g/L.
• Failure or intolerance to at least 3 lines of therapy, including glucocorticoids, rituximab, cyclophosphamide, azathioprine, fludarabine, cyclosporine, mycophenolate mofetil, Bruton's tyrosine kinase inhibitors, splenectomy.
• Laboratory tests of adequate organ function: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥40ml/min; Absolute neutrophil count (ANC) ≥1.0×10\^9/L (growth factors such as granulocyte colony-stimulating factor \[G-CSF\] were not received within 7 days before the screening period); Left ventricular ejection fraction (LVEF) ≥45%; Blood oxygen saturation (SpO2) ≥92%.
• Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 6-month safety follow-up period. Female subjects of childbearing potential must have a negative Serum HCG test within 7 days before enrollment and not in the lactation period.

You may not qualify if:

• Clear diagnosis of lymphoproliferative tumor.
• The platelet count in peripheral blood during the screening period is \<20×10\^9/L.
• Have a history of severe drug allergy or allergic constitution.
• Have a history of any of the following diseases: craniocerebral trauma, consciousness disorder, epilepsy, cerebrovascular ischemia, cerebrovascular, and hemorrhagic diseases within 6 months before enrollment.
• Have any of the following serious cardiovascular diseases: myocardial infarction within 6 months before enrollment, cardiac angioplasty or stent implantation); Unstable angina; Severe cardiac arrhythmias; History of severe nonischemic cardiomyopathy; Congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)).
• Have malignant tumors within 5 years before enrollment, unless any of the following conditions: fully treated cervical carcinoma in situ, fully treated basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical mastectomy, breast ductal carcinoma in situ after radical mastectomy, Carcinoma in situ in other locations one year after radical resection, and these diseases have no evidence of relapse.
• Subjects with any serious active fungal, bacterial, viral, tuberculosis or other infections, including active hepatitis B (defined as serum HBV-DNA ≥ 2000 IU/mL), active hepatitis C virus (Hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) antibody-positive or active syphilis patients, etc. Subjects whose HBV-DNA \< 2000 IU/mL can be included on the condition that they receive antiviral drugs and monitor the related indicators during the study.
• Have mental illness and severe cognitive impairment.
• Have a history of live attenuated vaccines within 4 weeks before enrollment.
• Subjects considered to be ineligible for the study by the investigator for reasons other than the above.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Suzhou Fundamenta Therapeutics: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune; Recurrence

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jun Shi, PhD

CONTACT

13752253515; shijun@ihcams.ac.cn

Hong Pan, MD

CONTACT

panhong@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Regenerative Medicine Center

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CN (1)