Autoimmune Hemolytic AnemiaEarly Phase 1NCT07441525
UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
A Early Phase 1 study testing CART Infusion in people with Autoimmune Hemolytic Anemia and Primary Immune Thrombocytopenic Purpura, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated autoimmune hematological diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Hemolytic Anemia, Primary Immune Thrombocytopenic Purpura, Evans Syndrome
- What is being tested?
- CART Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to 30 Jun 2029
- 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
- Subjects voluntarily participate in this trial and sign the informed consent form.
- Aged ≥ 18 years and ≤ 75 years, regardless of gender.
- Organ function and laboratory tests:
- Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for Gilbert's Syndrome).
- Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance Rate ≥ 40 ml/min.
- Oxygen saturation (SpO2) ≥ 92% in room air at rest.
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- Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening.
- Female subjects of childbearing potential must agree to use highly effective contraceptive methods from at least 28 days before the start of lymphodepletion to 12 months after reinfusion on RD06-05. Male subjects of childbearing potential must agree to use effective barrier contraceptive methods from the start of lymphodepletion to 12 months after reinfusion on RD06-05, and must not donate semen or sperm during the entire trial period.
- Subjects with primary Immune Thrombocytopenia (ITP), with a disease duration of at least > 6 months.
- Refractory or relapsed ITP: Subjects show no response, unsustained response, or intolerance to at least 2 different categories of standard treatments (e.g., glucocorticoids, splenectomy, intravenous immunoglobulin (IVIg), thrombopoietin receptor agonists (TPO-RA), Bruton's tyrosine kinase (BTK) inhibitors, etc.); among which, subjects must have received at least one or more treatments from IVIg, TPO-RA, or BTK inhibitors. In addition, platelet counts must be < 30,000/μL in two tests conducted within 15 days before the start of study treatment, with an interval of at least 7 days between the two tests.
- Complete blood count: Neutrophil count ≥ 1,000/µL, hemoglobin ≥ 60g/L.
- Subjects with Autoimmune Hemolytic Anemia (AIHA), including warm autoimmune hemolytic anemia (wAIHA), mixed autoimmune hemolytic anemia (mix-AIHA), and cold agglutinin disease (CAD), with a disease duration of at least > 6 months.
- Refractory or relapsed AIHA: Subjects show no response, unsustained response, or intolerance to at least 3 lines of systemic treatments (e.g., glucocorticoids, rituximab, immunosuppressants, splenectomy, complement inhibitors, etc.).
- Laboratory evidence of hemolysis: At least one of the following conditions exists in either the screening period or any test within the past 3 months: haptoglobin below the lower limit of normal, or total bilirubin (especially indirect bilirubin) above the upper limit of normal, or lactate dehydrogenase (LDH) above the upper limit of normal, and/or elevated reticulocyte count.
- Complete blood count: Neutrophil count ≥ 1,000/µL, hemoglobin (Hb) < 100g/L.
- Diagnosed with Evans Syndrome (ES), with a disease duration of at least > 6 months.
- Refractory or relapsed ES: After at least 3 lines of systemic treatments (e.g., glucocorticoids, intravenous immunoglobulin (IVIg), rituximab, immunosuppressants, splenectomy, thrombopoietin receptor agonists (TPO-RA), complement inhibitors, etc.), at least one type of cytopenia (thrombocytopenia or hemolytic anemia) still shows no response, unsustained response, or intolerance.
- Laboratory evidence of active blood cell destruction: Platelet count < 30,000/μL or manifestations of hemolysis exist during the screening period or within the past 3 months, such as haptoglobin < lower limit of normal, or total bilirubin (especially indirect bilirubin) > upper limit of normal, or LDH > upper limit of normal, and/or elevated reticulocyte count.
- Definite response to at least one previous treatment:
- Platelet (PLT) treatment response: Platelet count reaches ≥ 50,000/μL in at least 2 tests, with an increase of ≥ 20,000/μL compared to the baseline.
- Hemoglobin (Hb) treatment response: Hb increases by ≥ 10-15 g/L or hemolysis indicators improve.
Who cannot join
- Has a coexisting autoimmune disease that may seriously interfere with the attribution of study disease activity or pose additional safety risks. However, if the subject's condition has been clinically stable for ≥ 3 months, and it is expected not to interfere with study assessments, the subject may be enrolled after confirmation by the investigator and approval by the sponsor's medical monitor (or their designee).
- Has rapidly progressive glomerulonephritis (RPGN), defined as any of the following:
- Renal biopsy shows crescent formation in ≥ 50% of glomeruli.
- Sustained doubling of serum creatinine level within 2 months before screening.
- The investigator assesses that the subject has RPGN.
- Subjects with the following cardiac diseases will be excluded:
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- History of heart failure classified as New York Heart Association (NYHA) Class III or IV.
- History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious cardiac diseases within 12 months before enrollment.
- Has a history of severe central nervous system (CNS) diseases that may affect the subject's ability to comply with the study protocol or interfere with the accuracy of study assessments, such as: traumatic brain injury, disturbance of consciousness, epilepsy, cerebral vascular ischemia, or cerebral vascular hemorrhage.
- Has a history of malignant tumors other than cured non-melanoma skin cancer or carcinoma in situ (e.g., carcinoma in situ of the cervix, bladder, or breast), unless the subject has been disease-free for at least 3 years.
- Primary immunodeficiency.
- Has uncontrolled infection; simple urinary tract infections and upper respiratory tract infections are permitted as judged by the investigator and the sponsor's medical monitor (or their designee).
- Has a known history of infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or syphilis.
- Active or latent hepatitis B virus (HBV) infection.
- Positive results for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA or IgM antibodies during the screening period.
- Has a history of recurrent tuberculosis or known recurrent tuberculosis.
- Has a history of previous chimeric antigen receptor T-cell (CAR-T) therapy or any other genetically modified immune cell therapy.
- Has received a live-attenuated vaccine within 4 weeks before enrollment.
- Has a history of allergy to any component of the cell therapy product.
- Has a history of hypersensitivity to tacrolimus, or has experienced ≥ Grade 3 tacrolimus-related toxicity in the past (including but not limited to neurological, gastrointestinal, hepatic, renal, or hematological toxicity), especially subjects who required hospitalization will be excluded. Other cases may be considered eligible after confirmation by the investigator and the sponsor's medical monitor (or their designee).
- Has participated in another clinical trial within 30 days before screening.
- Pregnant or lactating subjects, as well as subjects of childbearing potential who cannot take effective contraceptive measures.
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
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei
Wei Xie, Attending Physician, 027-8572600, sherryxw@163.com
Heng Mei, Prof.
About this study
Official title: Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated autoimmune hematological diseases. The enrolled population consists of patients with active autoimmune hematological diseases, including primary immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), and Evans syndrome.
This study sets two dose groups: 6 × 10⁶ CAR⁺T cells/kg and 10 × 10⁶ CAR⁺T cells/kg, with the initial dose being 6 × 10⁶ CAR⁺T cells/kg. To reduce efficacy risks, the dose may be escalated to 10 × 10⁶ CAR⁺T cells/kg following evaluation and recommendation by the Safety Review Committee (SRC). The SRC's recommendation on dose escalation will be based on a comprehensive assessment of all available safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data.
- Being tested
- CART Infusion
- Keywords
- UCART, CD19/BCMA, ITP, AIHA, EVANS
- Medical subject headings
- Anemia, Hemolytic, Autoimmune, Evans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART InfusionDrug
All participants will recevie CAR+T cells infusion with dose groups of 6 × 10⁶ CAR+T cells/kg and 10 × 10⁶ CAR+T cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| CART Treatment Group | Experimental | All participants will recevie CAR+T cells infusion with dose groups of 6 × 10⁶ CAR+T cells/kg and 10 × 10⁶ CAR+T cells/kg. Receives: Drug: CART Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rates of Serious Adverse Events that occur during treatment
Measured: From the day of cell infusion to months 24 after cell infusion
The incidence rates of Treatment-Emergent Adverse Events that occur during treatment
Measured: From the day of cell infusion to months 24 after infusion
The incidence rates of Adverse Events of Special Interest that occur during treatment
Measured: From the day of cell infusion to months 24 after cell infusion
Secondary outcomes (15)
ITP: The proportion of subjects who achieve a sustained platelet response
Measured: From the day of cell infusion to months 24 after cell infusion
ITP: Overall Response Rate (ORR)
Measured: From the day of cell infusion to months 24 after cell infusion
ITP: Complete Response Rate (CR)
Measured: From the day of cell infusion to months 24 after cell infusion
ITP: PartialResponse Rate (PR)
Measured: From the day of cell infusion to months 24 after cell infusion
ITP: Duration of Sustained Platelet Response
Measured: From the day of cell infusion to months 24 after cell infusion
ITP: Duration of Complete Response
Measured: From the day of cell infusion to months 24 after cell infusion
AIAH: The proportion of subjects who achieve a durable hemoglobin response
Measured: From the day of cell infusion to months 24 after cell infusion
AIAH: Overall Response Rate (ORR)
Measured: From the day of cell infusion to months 24 after cell infusion
AIAH: Complete Response Rate (CR)
Measured: From the day of cell infusion to months 24 after cell infusion
AIAH: PartialResponse Rate (PR)
Measured: From the day of cell infusion to months 24 after cell infusion
AIAH: Complete Hematologic Response with CompensatedHemolysis (CRi)
Measured: From the day of cell infusion to months 24 after cell infusion
AIAH: Duration of Response (DOR)
Measured: From the day of cell infusion to months 24 after cell infusion
Evans Syndrome: CR: Shall include both AIHA-CR and ITP-CR.
Measured: From the day of cell infusion to months 24 after cell infusion
Evans Syndrome: PR: AIHA/ITP (either) achieves CR/PR, or both achieve PR
Measured: From the day of cell infusion to months 24 after cell infusion
EVANS Syndrome: Duration of response
Measured: From the day of cell infusion to months 24 after cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start3 Feb 2026
- Primary completion10 Jan 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Model description
- All participanets will receive cell infusion.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441525
- Sponsor's protocol ID
- BHCT-RD06-05-BHD
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
- ClinicalTrials.gov ID
- NCT07441525
- Acronym / sponsor ID
- BHCT-RD06-05-BHD
- Keywords
- UCART, CD19/BCMA, ITP, AIHA, EVANS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 10 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 2 Mar 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 a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated autoimmune hematological diseases. The enrolled population consists of patients with active autoimmune hematological diseases, including primary immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), and Evans syndrome.
This study sets two dose groups: 6 × 10⁶ CAR⁺T cells/kg and 10 × 10⁶ CAR⁺T cells/kg, with the initial dose being 6 × 10⁶ CAR⁺T cells/kg. To reduce efficacy risks, the dose may be escalated to 10 × 10⁶ CAR⁺T cells/kg following evaluation and recommendation by the Safety Review Committee (SRC). The SRC's recommendation on dose escalation will be based on a comprehensive assessment of all available safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participanets will receive cell infusion.
| Arm | Type | Receives |
|---|---|---|
| CART Treatment Group | Experimental | Drug: CART InfusionAll participants will recevie CAR+T cells infusion with dose groups of 6 × 10⁶ CAR+T cells/kg and 10 × 10⁶ CAR+T cells/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subjects voluntarily participate in this trial and sign the informed consent form.
- Aged ≥ 18 years and ≤ 75 years, regardless of gender.
- Organ function and laboratory tests:
- Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening.
- Female subjects of childbearing potential must agree to use highly effective contraceptive methods from at least 28 days before the start of lymphodepletion to 12 months after reinfusion on RD06-05. Male subjects of childbearing potential must agree to use effective barrier contraceptive methods from the start of lymphodepletion to 12 months after reinfusion on RD06-05, and must not donate semen or sperm during the entire trial period.
Key exclusion criteria (22 listed)
- Has a coexisting autoimmune disease that may seriously interfere with the attribution of study disease activity or pose additional safety risks. However, if the subject's condition has been clinically stable for ≥ 3 months, and it is expected not to interfere with study assessments, the subject may be enrolled after confirmation by the investigator and approval by the sponsor's medical monitor (or their designee).
- Has rapidly progressive glomerulonephritis (RPGN), defined as any of the following:
- Subjects with the following cardiac diseases will be excluded:
- Has a history of severe central nervous system (CNS) diseases that may affect the subject's ability to comply with the study protocol or interfere with the accuracy of study assessments, such as: traumatic brain injury, disturbance of consciousness, epilepsy, cerebral vascular ischemia, or cerebral vascular hemorrhage.
- Has a history of malignant tumors other than cured non-melanoma skin cancer or carcinoma in situ (e.g., carcinoma in situ of the cervix, bladder, or breast), unless the subject has been disease-free for at least 3 years.
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 |
|---|---|---|
| CART InfusionAll participants will recevie CAR+T cells infusion with dose groups of 6 × 10⁶ CAR+T cells/kg and 10 × 10⁶ CAR+T cells/kg. | Drug | CART Treatment Group |
Primary outcome
The incidence rates of Serious Adverse Events that occur during treatment
Time frame: From the day of cell infusion to months 24 after cell infusion
The incidence rates of Treatment-Emergent Adverse Events that occur during treatment
Time frame: From the day of cell infusion to months 24 after infusion
The incidence rates of Adverse Events of Special Interest that occur during treatment
Time frame: From the day of cell infusion to months 24 after cell infusion
15 secondary outcomes
ITP: The proportion of subjects who achieve a sustained platelet response
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Overall Response Rate (ORR)
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Complete Response Rate (CR)
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: PartialResponse Rate (PR)
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Duration of Sustained Platelet Response
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Duration of Complete Response
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: The proportion of subjects who achieve a durable hemoglobin response
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Overall Response Rate (ORR)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Complete Response Rate (CR)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: PartialResponse Rate (PR)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Complete Hematologic Response with CompensatedHemolysis (CRi)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Duration of Response (DOR)
Time frame: From the day of cell infusion to months 24 after cell infusion
Evans Syndrome: CR: Shall include both AIHA-CR and ITP-CR.
Time frame: From the day of cell infusion to months 24 after cell infusion
Evans Syndrome: PR: AIHA/ITP (either) achieves CR/PR, or both achieve PR
Time frame: From the day of cell infusion to months 24 after cell infusion
EVANS Syndrome: Duration of response
Time frame: From the day of cell infusion to months 24 after 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 2 Mar 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 CART Infusion in people with Autoimmune Hemolytic Anemia and Primary Immune Thrombocytopenic Purpura, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 22 inclusion and 22 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 2 Mar 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 Wei Xie, Attending Physician (027-8572600, sherryxw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rates of Serious Adverse Events that occur during treatment (time frame: From the day of cell infusion to months 24 after cell 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 2 Mar 2026.