Actively Recruiting
CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-07-24
15
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
N
Nanjing Bioheng Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is exploratory research aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD13-02, a universal CD7 CAR T therapy, in subjects with relapsed/refractory severe aplastic anemia (SAA)
CONDITIONS
Official Title
CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Age between 18 and 75 years.
- Diagnosed with severe aplastic anemia according to UK Hematology Guidelines.
- Had at least one course of standard-dose therapy with ATG or ALG combined with TPO-RA that was ineffective or relapsed within the past 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Willing and able to comply with the study procedures.
You will not qualify if you...
- Blood cell reduction and hypoplastic bone marrow diseases caused by other conditions like hemolytic PNH, hypoplastic MDS/AML, or antibody-mediated pancytopenia.
- Received ATG/ALG treatment less than 6 months ago or TPO-RA treatment less than 4 months ago.
- Significant neurological disease history, such as dementia, stroke without paralysis, aphasia, seizures, or any neurological condition posing safety risks for cell therapy.
- History of allogeneic bone marrow or stem cell transplantation, solid organ transplantation, or plans for such transplantation.
- History of autologous or allogeneic CAR T therapy.
- Any primary immunodeficiency disease.
- Significant cardiovascular dysfunction or history including congestive heart failure NYHA class III or higher within 12 months, low left ventricular ejection fraction, serious arrhythmias, myocardial infarction, significant valvular heart disease, recurrent syncope, or thromboembolic events.
- Liver or lung dysfunction defined by elevated liver enzymes, bilirubin, or pulmonary hypertension.
- Prolonged QTc interval on ECG.
- History of malignancy except certain treated or removed non-melanoma skin cancers or in situ cancers without residual disease.
- Pregnant or breastfeeding females, or planning pregnancy during the study or within 12 months after infusion.
- History or signs of significant chronic active or recurrent infections requiring treatment.
- Uncontrolled infections at screening except certain uncomplicated infections with approval.
- Positive for hepatitis B surface antigen, hepatitis C RNA, or HIV; certain hepatitis B DNA positive cases excluded.
- Recent vaccination with live attenuated vaccines or plans to receive during the study.
- Coagulation abnormalities except patients on stable anticoagulants who can discontinue treatment.
- Severe kidney dysfunction with eGFR below 30 mL/min/1.73 m².
- History of drug or alcohol abuse within the past year.
- Currently enrolled or recently ended participation in other experimental studies.
- History of hypersensitivity or life-threatening reactions to study drug components.
- Any condition that may affect participation, pose safety risks, or confound study results as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Regenerative Medicine Clinic Center
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jun Shi, PhD
CONTACT
L
Lele Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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