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New treatment option for Severe Aplastic Anemia
Official title CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia
ClinicalTrials.gov ID: NCT06622694
What this study is testing
What is RD13-02?
RD13-02 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for severe aplastic anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Willing and able to provide written informed consent.
- Age ≥18 years and ≤75 years.
- Diagnosed with severe aplastic anemia: Diagnostic criteria refer to the UK Hematology Guidelines (Br J Haematol, 2024, 204(3): 784-804): 1) Bone...
- Had at least one course of standard-dose therapy with anti-thymocyte globulin (ATG) or anti-lymphocyte globulin (ALG) combined with TPO-RA that was...
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
You likely can't join if
- Blood cell reduction and hypoplastic bone marrow diseases due to other causes (e.g., hemolytic PNH, hypoplastic MDS/AML, antibody-mediated...
- Received ATG/ALG treatment less than 6 months ago; received TPO-RA treatment less than 4 months ago. Note: Patients on stable doses of cyclosporine...
- Significant neurological disease history, including dementia, stroke without paralysis, aphasia, seizures, or any neurological history that may pose...
- History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart), or plans for such...
- History of autologous or allogeneic CAR T therapy.
- Any primary immunodeficiency disease.
See the full eligibility criteria
Who can join
- Willing and able to provide written informed consent.
- Age ≥18 years and ≤75 years.
- Diagnosed with severe aplastic anemia: Diagnostic criteria refer to the UK Hematology Guidelines (Br J Haematol, 2024, 204(3): 784-804): 1) Bone marrow cellularity \<25% (or 25-50% but \<30% residual hematopoietic cell...
- Had at least one course of standard-dose therapy with anti-thymocyte globulin (ATG) or anti-lymphocyte globulin (ALG) combined with TPO-RA that was ineffective or relapsed after remission within the past 6 months.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Willing and able to comply with the study procedures.
What rules you out
- Blood cell reduction and hypoplastic bone marrow diseases due to other causes (e.g., hemolytic PNH, hypoplastic MDS/AML, antibody-mediated pancytopenia).
- Received ATG/ALG treatment less than 6 months ago; received TPO-RA treatment less than 4 months ago. Note: Patients on stable doses of cyclosporine or hematopoietic agents at screening can be enrolled if laboratory...
- Significant neurological disease history, including dementia, stroke without paralysis, aphasia, seizures, or any neurological history that may pose safety risks regarding cell therapy as judged by the investigator.
- History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart), or plans for such transplantation in the future.
- History of autologous or allogeneic CAR T therapy.
- Any primary immunodeficiency disease.
- Significant cardiovascular dysfunction history or current significant cardiovascular dysfunction, particularly:
- Signs or symptoms of congestive heart failure classified as NYHA class ≥III within 12 months prior to enrollment.
- Echocardiogram showing left ventricular ejection fraction (LVEF) \<45% (assessed during screening).
- History of any serious arrhythmia, currently on treatment for arrhythmias, significant history of myocardial infarction, clinically significant valvular heart disease (including mild or greater aortic regurgitation or...
- Liver or lung dysfunction, defined as:
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥2.5× the upper limit of normal (ULN);
- Total bilirubin ≥1.5×ULN, except in people with Gilbert's syndrome.
- Pulmonary hypertension, including secondary pulmonary hypertension, classified as WHO functional class \>2.
- Males with QTcF \>450 msec; females with QTcF \>470 msec, based on a single ECG or the average of three repeat ECGs taken more than 3 minutes apart.
- History of malignancy, excluding adequately treated or surgically removed non-melanoma skin cancer or in situ cancers (e.g., cervical cancer, bladder cancer, breast cancer) without residual disease.
- Pregnant or breastfeeding females, or females planning to become pregnant during the study or within 12 months after RD13-02 infusion.
- History or signs of significant chronic active or recurrent infections, or significant chronic active or recurrent infections requiring antibiotics, antivirals, or antifungal treatments based on screening laboratory...
- Uncontrolled infections at screening. Patients with uncomplicated urinary tract infections (UTIs) and uncomplicated bacterial pharyngitis responding to active treatment may be included with investigator and medical...
- Positive screening for HBsAg, HCV RNA, or HIV. If a subject is HBsAg negative but HBcAb positive, hepatitis B virus DNA testing should be performed; people with positive hepatitis B virus DNA should be excluded from the...
- Vaccination with live attenuated vaccines within 4 weeks prior to enrollment, or plans to receive live attenuated vaccines during the study.
- PT, APTT, or INR \>1.2×ULN, except for people on stable doses of anticoagulants who can discontinue treatment prior to using intravenous access procedures.
- eGFR \<30 mL/min/1.73 m² calculated using the CKD-EPI formula; if eGFR ≥30 mL/min/1.73 m² but \<45 mL/min/1.73 m², adjust fludarabine dosing in the lymphodepleting regimen based on renal function.
- History of drug or alcohol abuse within the past year.
- Currently enrolled in other experimental device or drug studies, or less than 30 days since ending other experimental device or drug interventions, or less than 5 half-lives (whichever is longer).
- History of hypersensitivity or life-threatening reactions to any component or formulation of the study drug or treatment (including lymphodepleting regimen). For detailed information about study drug components, refer...
- Any condition the investigator believes may affect participation, pose safety risks to the people, or potentially confound the interpretation of study results.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.