META 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia

NCT07689604 | Not Yet Recruiting Early Phase 1

• 1 other identifier: LM-MATE10-19-19
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia

Conditions

Autoimmune Hemolytic Anemia (AIHA)

Keywords

META 10-19; Relapsed/Refractory Autoimmune Hemolytic Anemia (AIHA); IL-10

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Assessed by CTCAE Version 6.0.

  Up to 28 days after META 10-19 infusion.

Secondary Outcomes (5)

• Proportion of patients achieving response

  On Day 28 and at Months 2, 3, and 6 after META 10-19 infusion.

• The maximum concentration (Cmax)

  Up to 6 months after META 10-19 infusion.

• Time to Peak (Tmax)

  Up to 6 months after META 10-19 infusion.

• AUC(0-day 28)

  Up to 28 days after META 10-19 infusion.

• Pharmacodynamics

  Up to 6 months after META 10-19 infusion.

Study Arms (1)

META 10-19 CAR T-Cell Therapy

EXPERIMENTAL

Participants will receive META 10-19 CAR T-cell infusion. Participants will be closely monitored for 24 hours after infusion. Hospitalization for a minimum of 14 days after infusion is recommended. The duration of hospitalization and observation will be determined based on the investigator's clinical assessment of the participant's condition.

Biological: Metabolically Armed Autologous CD19 CAR T-Cell therapy

Interventions

Metabolically Armed Autologous CD19 CAR T-Cell therapy BIOLOGICAL

Metabolically Armed Autologous CD19 CAR T-cells. Each subject receive metabolically autologous armed CD19 CAR T-cells by intravenous infusion.

Also known as: META 10-19

META 10-19 CAR T-Cell Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years, regardless of genders.
• Diagnosis of AIHA (including warm antibody type, mixed warm and cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with the Chinese Expert Consensus on the Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), or the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults: Recommendations from the First International Consensus Meeting (Blood Rev, 2020), or the Chinese Expert Consensus on the Diagnosis and Treatment of Evans Syndrome (2024 Edition).
• Definition of relapsed/refractory disease, meeting all of the following criteria:
• Hemoglobin \< 10 g/dL with clinical manifestations of hemolytic anemia;
• After treatment with at least two immunosuppressive agents (which must include an anti-CD20 monoclonal antibody, with a cumulative dose of the anti-CD20 antibody reaching at least 375 mg/m² × 4, or a total dose of 2.0 g, or at least 6 cumulative administrations with an interval of ≥1 week between each);
• Glucocorticoid therapy for no less than 3 months (except for those with comorbidities that contraindicate corticosteroid use, severe infection, severe osteoporosis, previous fractures, or intolerance to glucocorticoids).
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
• Estimated life expectancy ≥12 weeks;
• Adequate organ function as assessed by laboratory tests: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); and minimal pulmonary reserve, defined as dyspnea ≤ grade 1 and oxygen saturation ≥ 93% while breathing room air; creatinine clearance (estimated by Cockcroft-Gault) ≥ 45 mL/min; cardiac ejection fraction ≥ 50%, with no signs of pericardial effusion on echocardiography (ECHO) and no clinically significant electrocardiogram (ECG) abnormalities.
• During the study period (from the signing of this informed consent form until at least 12 months after META 10-19 infusion, and until two consecutive PCR tests show no detectable CAR-T cells in the body), the study participant and their spouse/partner must use appropriate and effective contraceptive measures (excluding rhythm method/calendar-based contraception).
• Study participants must sign a written informed consent form approved by the Ethics Committee prior to the initiation of any screening procedures.

You may not qualify if:

• Previously diagnosed definite lymphoproliferative neoplasms; other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, breast carcinoma in situ, and cervical carcinoma in situ).
• Secondary AIHA caused by drugs or infection.
• Presence of active hepatitis or a history of severe liver disease or condition during the screening period:
• Hepatitis B: HBsAg or HBeAg positive; or hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive with HBV-DNA copy number above the lower limit of detection.
• Hepatitis C: Anti-HCV positive and HCV RNA ≥ lower limit of quantification (LLoQ).
• Human immunodeficiency virus (HIV) antibody positive.
• Active syphilis infection (excluding those with only positive syphilis-specific antibodies).
• Previous history of organ transplantation or hematopoietic stem cell transplantation.
• Severe cardiovascular diseases:
• Cardiovascular disease with New York Heart Association (NYHA) class \> 2 within 6 months prior to the first study drug administration.
• Unstable angina or severe arrhythmia requiring medication, including QTcF \> 480 ms (calculated by Fridericia's formula).
• Other significant electrocardiogram (ECG) abnormalities, including second-degree type II atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate \< 50 bpm with clinical symptoms), etc.
• Myocardial infarction within the past 6 months.
• Other cardiac diseases considered unsuitable for enrollment by the investigator.
• Undergone major surgery within the past 4 weeks that is deemed by the investigator as unsuitable for enrollment.

Sponsors & Collaborators

• Hangzhou Leman Biotech Co., Ltd: collaborator
• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

RuoNan Li

CONTACT

86+18810169952; liruonan@ihcams.ac.cn

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: Director of the Red Blood Cell Diseases Center & Director of the Regenerative Medicine Clinic

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)