Transplantation Candidates With Hematological DiseasesPhase 1/2NCT07451236
CD19-BCMA Dual Nanobody Based CAR-T Cells for Patients With DSA
A Phase 1/2 study testing CD19-BCMA dual nanobody based CAR-T Cells in people with Transplantation Candidates With Hematological Diseases, run by Chang Yingjun.
Trial summary
This is an early-stage, open-label clinical study of CD19-BCMA dual nanobody based CAR-T Cell desensitization therapy for patients positive for Donor-Specific Antibodies. Enrolled subjects will participate in an early clinical study using the traditional "3+3" dose escalation design to determine the Maximum Tolerated… Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Transplantation Candidates With Hematological Diseases
- What is being tested?
- CD19-BCMA dual nanobody based CAR-T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2026to 31 Dec 2027
- Phase
- Phase 1/2
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject or their legal guardian understands and voluntarily signs the Informed Consent Form (ICF).
- Male or female, aged 3 years or older (inclusive) at the time of signing the ICF.
- Expected survival period is not less than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 at the time of signing the ICF.
- At the time of signing the ICF, the following must be satisfied:
- Meets the indications for allogeneic hematopoietic stem cell transplantation, is at a suitable stage for transplantation, and is planned to receive a haploidentical related donor allogeneic hematopoietic stem cell transplant.
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- The patient has no available HLA-matched sibling donor, no other HLA-matched unrelated donor, and no related donor who is DSA-negative.
- The patient has a DSA level ≥5000 MFI.
- Major organ function must meet the following requirements:
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 5 × Upper Limit of Normal (ULN).
- Total bilirubin ≤ 2 × ULN.
- For adult subjects: Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) OR Serum creatinine ≤ 1.5 × ULN.
- For pediatric subjects: Serum creatinine must not exceed: 1.2 mg/dL for ages 12-13; 1.5 mg/dL for males aged 13-16; 1.4 mg/dL for females aged >13; 1.7 mg/dL for males aged >16.
- HBV-DNA, HCV-RNA, Syphilis antibody, HIV antibody, CMV/EBV DNA must be negative; no active infection.
- Oxygen saturation > 92%.
- Men and women of childbearing potential must agree to use effective contraception from the time of signing the ICF until 2 years after administration of the study drug. Women of childbearing potential include premenopausal women and women within 2 years of menopause. A negative blood pregnancy test is required for women of childbearing potential at screening.
Who cannot join
- History of central nervous system (CNS) diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy. Subjects with a history of conditions like lacunar infarction without related neurological symptoms before screening may be considered for exclusion based on the investigator's judgment.
- Other severe, progressive, or uncontrolled gastrointestinal, urinary, endocrine, or respiratory diseases, deemed by the investigator as unsuitable for enrollment.
- Participation in another clinical trial within 2 weeks prior to screening.
- Other factors that may influence DSA levels: Received proteasome inhibitors or BTK inhibitors, rituximab, or other monoclonal antibodies targeting B cells or plasma cells (e.g., belimumab, telitacicept, daratumumab) within 2 weeks prior to signing the ICF.
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to leukapheresis.
- Positive HBsAg or positive HBcAb with detectable HBV DNA at screening; Positive HCV antibody with detectable HCV RNA at screening; Positive HIV antibody; Positive CMV DNA; Positive EBV DNA; Positive for both treponemal and non-treponemal syphilis antibodies.
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- Clinically significant cardiovascular diseases, including any of the following:
- QTc interval ≥ 480 ms (corrected using Fridericia's formula).
- New York Heart Association (NYHA) Class II or higher heart failure.
- Unstable angina or acute myocardial infarction within 6 months prior to signing the ICF.
- Left Ventricular Ejection Fraction (LVEF) < 50%.
- Poorly controlled hypertension (judged by the investigator based on the subject's individual condition).
- Clinically significant arrhythmias requiring antiarrhythmic treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, complete left bundle branch block, etc.).
- Allergy to any component of the drugs used in this study.
- Received large-field radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions during the study period.
- Requirement for systemic corticosteroids (at a dose equivalent to or higher than prednisone 10 mg/day) or other immunosuppressive drugs within 3 days prior to leukapheresis or anticipated during the study period, except for the following:
- Nasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular).
- Systemic corticosteroid therapy not exceeding prednisone 10 mg/day or an equivalent physiological dose.
- Steroids used as premedication for allergic reactions (e.g., pre-CT scan).
- Used for managing adverse reactions post-infusion.
- Major surgical procedure within 4 weeks prior to signing the ICF (excluding routine biopsy surgery), or anticipated major surgery during the study period.
- History of active tuberculosis infection within 1 year prior to signing the ICF (subjects with a history of active tuberculosis more than 1 year ago may be included if the investigator judges there is no current evidence of active tuberculosis).
- Administration of live/attenuated or inactivated vaccines within 4 weeks prior to signing the ICF, or planned administration during the screening period.
- Pregnant or lactating women.
- Men or women who refuse to use contraception from the time of signing the ICF until 12 months after study completion.
- History of alcohol abuse, drug abuse, or psychiatric history.
- Any comorbidities or other conditions that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Trial of CD19-BCMA Dual Nanobody Based CAR-T Cells for Patients With Donor-specific Antibodies
This is an early-stage, open-label clinical study of CD19-BCMA dual nanobody based CAR-T Cell desensitization therapy for patients positive for Donor-Specific Antibodies. Enrolled subjects will participate in an early clinical study using the traditional "3+3" dose escalation design to determine the Maximum Tolerated Dose (MTD) of CAR-T cell infusion (i.e., three escalating dose levels: 0.5x10^6 CAR+ T cells/kg, 1x10^6 CAR+ T cells/kg, 2x10^6 CAR+ T cells/kg). The investigators and the sponsor will jointly form a Safety Review Committee (SRC). The final decision on whether to continue increasing the dose levels or to conduct an expansion study at a specific dose level will be based on the safety and efficacy data obtained from the three dose groups. Assessments will be performed every 4 weeks after cell infusion, with a total planned enrollment of 9-18 subjects.
- Being tested
- CD19-BCMA dual nanobody based CAR-T Cells
- Keywords
- Donor-Specific Antibody (DSA) ≥5000 MFI, CD19-BCMA dual nanobody based CAR-T Cells, Patients with hematological diseases, Allogeneic hematopoietic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-BCMA dual nanobody based CAR-T CellsBiological
Desensitization
| Study group | Role | What they receive |
|---|---|---|
| Patients with DSA | Experimental | Not described Receives: Biological: CD19-BCMA dual nanobody based CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Incidence and severity of AEs and SAEs within 1 month after cell infusion
The primary safety endpoint is the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) occurring within 30 days post-cell infusion. All events will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The analysis will summarize the frequency, severity (maximum grade), duration, and causality (as assessed by the investigator) of all reported AEs and SAEs. Special emphasis will be placed on the incidence of Grade ≥3 AEs, treatment-related SAEs, and AEs leading to discontinuation or death, providing a comprehensive assessment of the acute safety profile of the investigational cell product.
Measured: From enrollment to the end of treatment at 4-5 weeks
• Incidence and severity of ICANS
The primary safety endpoint is the incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), will be graded using the standardized American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Measured: From enrollment to the end of treatment at 4-5 weeks
Incidence and severity of ICAHT
The primary safety endpoint is the incidence and severity of immune effector cell-associated hematotoxicity (ICAHT), will be graded using European Hematology Association/European Society for Blood and Marrow Transplantation (EHA/EBMT) guidelines.
Measured: From enrollment to the end of treatment at 4-5 weeks
Secondary outcomes (1)
DSA seroconversion rate (≤ 2000 MFI) at 3 months post-infusion
DSA seroconversion rate (≤ 2000 MFI) at 3 months post-infusion
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start18 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation Candidates With Hematological DiseasesStudies of the same condition, open and under way.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Yingjun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang Yingjun, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451236
- Sponsor's protocol ID
- 2025PHD029
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of CD19-BCMA Dual Nanobody Based CAR-T Cells for Patients With Donor-specific Antibodies
- ClinicalTrials.gov ID
- NCT07451236
- Acronym / sponsor ID
- 2025PHD029
- Keywords
- Donor-Specific Antibody (DSA) ≥5000 MFI, CD19-BCMA dual nanobody based CAR-T Cells, Patients with hematological diseases, Allogeneic hematopoietic stem cell transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chang YingjunUniversity, hospital or other
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 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 an early-stage, open-label clinical study of CD19-BCMA dual nanobody based CAR-T Cell desensitization therapy for patients positive for Donor-Specific Antibodies. Enrolled subjects will participate in an early clinical study using the traditional "3+3" dose escalation design to determine the Maximum Tolerated Dose (MTD) of CAR-T cell infusion (i.e., three escalating dose levels: 0.5x10^6 CAR+ T cells/kg, 1x10^6 CAR+ T cells/kg, 2x10^6 CAR+ T cells/kg). The investigators and the sponsor will jointly form a Safety Review Committee (SRC). The final decision on whether to continue increasing the dose levels or to conduct an expansion study at a specific dose level will be based on the safety and efficacy data obtained from the three dose groups. Assessments will be performed every 4 weeks after cell infusion, with a total planned enrollment of 9-18 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DSA | Experimental | Biological: CD19-BCMA dual nanobody based CAR-T Cells |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- The subject or their legal guardian understands and voluntarily signs the Informed Consent Form (ICF).
- Male or female, aged 3 years or older (inclusive) at the time of signing the ICF.
- Expected survival period is not less than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 at the time of signing the ICF.
- At the time of signing the ICF, the following must be satisfied:
Key exclusion criteria (27 listed)
- History of central nervous system (CNS) diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy. Subjects with a history of conditions like lacunar infarction without related neurological symptoms before screening may be considered for exclusion based on the investigator's judgment.
- Other severe, progressive, or uncontrolled gastrointestinal, urinary, endocrine, or respiratory diseases, deemed by the investigator as unsuitable for enrollment.
- Participation in another clinical trial within 2 weeks prior to screening.
- Other factors that may influence DSA levels: Received proteasome inhibitors or BTK inhibitors, rituximab, or other monoclonal antibodies targeting B cells or plasma cells (e.g., belimumab, telitacicept, daratumumab) within 2 weeks prior to signing the ICF.
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to leukapheresis.
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 |
|---|---|---|
| CD19-BCMA dual nanobody based CAR-T CellsDesensitization | Biological | Patients with DSA |
Primary outcome
• Incidence and severity of AEs and SAEs within 1 month after cell infusion
Time frame: From enrollment to the end of treatment at 4-5 weeks
The primary safety endpoint is the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) occurring within 30 days post-cell infusion. All events will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The analysis will summarize the frequency, severity (maximum grade), duration, and causality (as assessed by the investigator) of all reported AEs and SAEs. Special emphasis will be placed on the incidence of Grade ≥3 AEs, treatment-related SAEs, and AEs leading to discontinuation or death, providing a comprehensive assessment of the acute safety profile of the investigational cell product.
• Incidence and severity of ICANS
Time frame: From enrollment to the end of treatment at 4-5 weeks
The primary safety endpoint is the incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), will be graded using the standardized American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Incidence and severity of ICAHT
Time frame: From enrollment to the end of treatment at 4-5 weeks
The primary safety endpoint is the incidence and severity of immune effector cell-associated hematotoxicity (ICAHT), will be graded using European Hematology Association/European Society for Blood and Marrow Transplantation (EHA/EBMT) guidelines.
1 secondary outcome
DSA seroconversion rate (≤ 2000 MFI) at 3 months post-infusion
Time frame: From enrollment to the end of treatment at 12 weeks
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 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Transplantation Candidates With Hematological Diseases
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19-BCMA dual nanobody based CAR-T Cells in people with Transplantation Candidates With Hematological Diseases, run by Chang Yingjun.
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 16 inclusion and 27 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ying-Jun Chang (86-13520536738, rmcyj@bjmu.edu.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 AEs and SAEs within 1 month after cell infusion (time frame: From enrollment to the end of treatment at 4-5 weeks). 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 6 Mar 2026.