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New treatment option for Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Official title Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL
ClinicalTrials.gov ID: NCT06880913
What this study is testing
What is Nanobody-Based CD19/CD22 Tandem Dual CAR-T?
Nanobody-Based CD19/CD22 Tandem Dual CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for precursor b-cell lymphoblastic leukemia-lymphoma.
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
- To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- The subject or their legally authorized representative (guardian) understands the study and voluntarily signs the informed consent form (ICF). Male...
- Bone marrow morphological examination at screening shows \>5% blasts in the bone marrow, and/or cerebrospinal fluid (CSF) analysis detects leukemic...
- Flow cytometry confirms CD19 or CD22 positivity in tumor cells from bone marrow, peripheral blood, or cerebrospinal fluid, or pathology confirms CD19...
- Eligibility for Phase II (RP2D) is restricted to patients with R/R B-ALL who have failed prior immunotherapies, including blinatumomab, inotuzumab...
- Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× upper limit of normal (ULN) Total bilirubin ≤2× ULN
You likely can't join if
- people who meet any of the following criteria will be excluded from the study:
- History of central nervous system (CNS) diseases, including but not limited to:
- Epilepsy
- Paralysis
- Aphasia
- Stroke
See the full eligibility criteria
Who can join
- The subject or their legally authorized representative (guardian) understands the study and voluntarily signs the informed consent form (ICF). Male or female, aged 12 to 65 years at the time of signing the ICF...
- Bone marrow morphological examination at screening shows \>5% blasts in the bone marrow, and/or cerebrospinal fluid (CSF) analysis detects leukemic cells, and/or the presence of measurable extramedullary lesions...
- Flow cytometry confirms CD19 or CD22 positivity in tumor cells from bone marrow, peripheral blood, or cerebrospinal fluid, or pathology confirms CD19 or CD22 positivity in lymph nodes/masses or extranodal lesions.
- Eligibility for Phase II (RP2D) is restricted to patients with R/R B-ALL who have failed prior immunotherapies, including blinatumomab, inotuzumab ozogamicin, or prior single-target CAR-T therapy. Adequate organ...
- Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× upper limit of normal (ULN) Total bilirubin ≤2× ULN
- Renal function: Adults: Serum creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula) or creatinine ≤1.5× ULN Children: Serum creatinine levels must not exceed the following values: 10-13 years: ≤1.2 mg/dL...
What rules you out
- people who meet any of the following criteria will be excluded from the study:
- History of central nervous system (CNS) diseases, including but not limited to:
- Epilepsy
- Paralysis
- Aphasia
- Stroke
- Severe brain injury
- Dementia
- Parkinson's disease
- Neuropathy
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:
- Crohn's disease
- Rheumatoid arthritis
- Systemic lupus erythematosus (SLE)
- Systemic sclerosis
- Inflammatory bowel disease (IBD)
- Vasculitis
- Psoriasis
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.
- Positive virological or infectious disease markers, including:
- Hepatitis B virus (HBV): people with positive HBsAg or HBcAb-positive at screening must have undetectable HBV DNA in peripheral blood to be eligible; otherwise, they should be excluded.
- Hepatitis C virus (HCV): people with positive HCV antibodies and detectable HCV RNA should be excluded.
- Human immunodeficiency virus (HIV) antibody-positive people should be excluded.
- Cytomegalovirus (CMV) DNA test-positive people should be excluded.
- Epstein-Barr virus (EBV) DNA test-positive people should be excluded.
- Positive serological or non-specific antibodies for Treponema pallidum (syphilis).
- Clinically significant cardiovascular diseases, including any of the following:
- QTc interval ≥480 ms (Fridericia correction 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 (as determined by the investigator)
- Clinically significant arrhythmias or those requiring antiarrhythmic treatment, including:
- Persistent ventricular tachycardia
- Ventricular fibrillation
- Torsades de pointes
- Complete left bundle branch block
- History of severe hypersensitivity or allergy to any components of the study drug.
- Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).
- Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study.
- Unresolved toxicity from prior antitumor therapy that has not returned to Grade 1 or baseline levels at the time of signing the ICF, except for hair loss and pigmentation (per NCI-CTCAE v5.0).
- Requirement for systemic corticosteroids or other immunosuppressive therapy (≥10 mg/day prednisone or equivalent) within 3 days prior to apheresis or during the study period, except for:
- Intranasal, inhaled, or topical steroids, or localized steroid injections (e.g., intra-articular injections)
- Systemic corticosteroids ≤10 mg/day prednisone (or equivalent physiological dose)
- Steroids as prophylaxis for allergic reactions (e.g., pre-medication before contrast-enhanced CT)
- Steroids used for symptomatic treatment of transfusion-related reactions
- Major surgery within 4 weeks prior to signing the ICF (excluding routine biopsy procedures) or planned major surgery during the study period.
- History of active tuberculosis infection within 1 year prior to signing the ICF, except for people with a history of tuberculosis more than 1 year ago, provided that the investigator determines there is no evidence of...
- History of other primary malignancies within 5 years prior to signing the ICF, except for:
- Adequately treated carcinoma in situ of the cervix
- Localized basal cell carcinoma or squamous cell carcinoma of the skin
- Receipt of live-attenuated or inactivated vaccines within 4 weeks before signing the ICF or planned vaccination during the screening period.
- Any other condition or complication that, in the investigator's judgment, may affect adherence to the study protocol or make the subject unsuitable for participation.
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing 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.