Autoimmune Hemolytic Anemia (AIHA)Early Phase 1NCT07689604
META 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
A Early Phase 1 study testing Metabolically Armed Autologous CD19 CAR T-Cell therapy in people with Autoimmune Hemolytic Anemia (AIHA), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Hemolytic Anemia (AIHA)
- What is being tested?
- Metabolically Armed Autologous CD19 CAR T-Cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 1 Oct 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Presence of active infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, active tuberculosis, etc.); active infection requiring intravenous anti-infective therapy within 7 days prior to screening.
- Receipt of CAR T-cell therapy within 6 months prior to screening, or positivity for ADA, or positivity for HAMA, or receipt of in vivo CAR T-cell therapy within the previous 6 months; or a history of severe immediate hypersensitivity reaction to any cellular product, excipients, or related drugs used in this study.
- Individuals with a history of epilepsy or other active central nervous system diseases (including but not limited to cerebrovascular accident, cerebral hemorrhage, cerebral infarction, severe traumatic brain injury, dementia, organic brain syndrome, etc.).
- Women with a positive pregnancy test or who are breastfeeding; women of childbearing potential and all male study participants who are unwilling or unable to use effective contraceptive methods during the study period and for at least 12 months after study drug infusion.
- Any other condition or circumstance that, in the investigator's opinion, would make the participant unsuitable for participation 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
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
RuoNan Li, 86+18810169952, liruonan@ihcams.ac.cn
Jun Shi
About this study
Official title: Phase I Clinical Study on the Safety and Tolerability of META 10-19 Infusion in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia
Read the detailed description
This is a Phase I clinical study evaluating metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in patients with relapsed/refractory autoimmune hemolytic anemia (AIHA). The main purpose of this study is to assess the safety and tolerability of this therapy in patients with relapsed/refractory AIHA.
-Primary Objective: To evaluate the safety and tolerability of metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in patients with relapsed/refractory autoimmune hemolytic anemia (AIHA).
-Secondary Objectives:
- To evaluate the preliminary efficacy of metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in study participants with relapsed/refractory AIHA.
- To assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the metabolically armed autologous CD19 CAR T-cell therapy (META 10-19).
- Conditions
- Autoimmune Hemolytic Anemia (AIHA)
- Being tested
- Metabolically Armed Autologous CD19 CAR T-Cell therapy
- Keywords
- META 10-19, Relapsed/Refractory Autoimmune Hemolytic Anemia (AIHA), IL-10
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolically Armed Autologous CD19 CAR T-Cell therapyBiological
Also called META 10-19
Metabolically Armed Autologous CD19 CAR T-cells. Each subject receive metabolically autologous armed CD19 CAR T-cells by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Metabolically Armed Autologous CD19 CAR T-Cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Assessed by CTCAE Version 6.0.
Measured: Up to 28 days after META 10-19 infusion.
Secondary outcomes (5)
Proportion of patients achieving response
Response is assessed based on hemoglobin (Hb), laboratory markers of hemolysis (serum bilirubin and lactate dehydrogenase), and transfusion requirements.
Measured: On Day 28 and at Months 2, 3, and 6 after META 10-19 infusion.
The maximum concentration (Cmax)
The Cmax of CAR-T cell expansion in peripheral blood.
Measured: Up to 6 months after META 10-19 infusion.
Time to Peak (Tmax)
The time to reach the maximum concentration (Tmax).
Measured: Up to 6 months after META 10-19 infusion.
AUC(0-day 28)
AUC(0- day28) refers to the area under curve of CAR T-cell expansion between infusion and day 28 post infusion.
Measured: Up to 28 days after META 10-19 infusion.
Pharmacodynamics
Pharmacodynamic effects will be assessed by changes in B-cell levels in peripheral blood and bone marrow, including percentage and absolute counts of B cells and plasma cells at different time points after infusion.
Measured: Up to 6 months after META 10-19 infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Hemolytic Anemia (AIHA)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Leman Biotech Co., Ltd
- Responsible party
- Principal investigator, Jun Shi, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689604
- Sponsor's protocol ID
- IIT2026058
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety and Tolerability of META 10-19 Infusion in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT07689604
- Acronym / sponsor ID
- IIT2026058
- Conditions
- Autoimmune Hemolytic Anemia (AIHA)
- Keywords
- META 10-19, Relapsed/Refractory Autoimmune Hemolytic Anemia (AIHA), IL-10
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Hangzhou Leman Biotech Co., Ltd
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 8 Jul 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.
A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia
Detailed description
This is a Phase I clinical study evaluating metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in patients with relapsed/refractory autoimmune hemolytic anemia (AIHA). The main purpose of this study is to assess the safety and tolerability of this therapy in patients with relapsed/refractory AIHA.
-Primary Objective: To evaluate the safety and tolerability of metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in patients with relapsed/refractory autoimmune hemolytic anemia (AIHA).
-Secondary Objectives:
- To evaluate the preliminary efficacy of metabolically armed autologous CD19 CAR T-cell therapy (META 10-19) in study participants with relapsed/refractory AIHA.
- To assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the metabolically armed autologous CD19 CAR T-cell therapy (META 10-19).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| META 10-19 CAR T-Cell Therapy | Experimental | Biological: Metabolically Armed Autologous CD19 CAR T-Cell therapyParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
- Estimated life expectancy ≥12 weeks;
Key exclusion criteria (20 listed)
- 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:
- Previous history of organ transplantation or hematopoietic stem cell transplantation.
- Severe cardiovascular diseases:
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 |
|---|---|---|
| Metabolically Armed Autologous CD19 CAR T-Cell therapyAlso: META 10-19Metabolically Armed Autologous CD19 CAR T-cells. Each subject receive metabolically autologous armed CD19 CAR T-cells by intravenous infusion. | Biological | META 10-19 CAR T-Cell Therapy |
Primary outcome
Incidence and severity of adverse events
Time frame: Up to 28 days after META 10-19 infusion.
Assessed by CTCAE Version 6.0.
5 secondary outcomes
Proportion of patients achieving response
Time frame: On Day 28 and at Months 2, 3, and 6 after META 10-19 infusion.
The maximum concentration (Cmax)
Time frame: Up to 6 months after META 10-19 infusion.
Time to Peak (Tmax)
Time frame: Up to 6 months after META 10-19 infusion.
AUC(0-day 28)
Time frame: Up to 28 days after META 10-19 infusion.
Pharmacodynamics
Time frame: Up to 6 months after META 10-19 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 21 Sep 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.
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 Metabolically Armed Autologous CD19 CAR T-Cell therapy in people with Autoimmune Hemolytic Anemia (AIHA), run by Institute of Hematology & Blood Diseases Hospital, China 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 11 inclusion and 20 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: opening soon, as of the sponsor's last update on 21 Sep 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 RuoNan Li (86+18810169952, liruonan@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: Up to 28 days after META 10-19 infusion.). 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 21 Sep 2026.