Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL

Recruiting now · Phase 1/Phase 2

Conditions studied: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

In brief

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

Key facts

Study ID

NCT06880913

Run by

Peking University People's Hospital

People needed

50

Starts

2024-11-14

Expected to finish

2028-12-31

Last updated by the study team

2026-03-30

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (inclusive of the cutoff values).
• Expected survival of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of signing the ICF.
• At the time of signing the ICF, the patient must be diagnosed with R/R B-ALL and meet the following criteria:
• 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, defined as:
• Any lymph node or mass with an axial diameter >1.5 cm Any extranodal lesion with an axial diameter >1.0 cm
• 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 function, meeting the following laboratory criteria:
• 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 Males 13-16 years: ≤1.5 mg/dL Females ≥13 years: ≤1.4 mg/dL Males ≥16 years: ≤1.7 mg/dL Blood oxygen saturation (SpO₂) >92% on room air. Fertile male and female subjects of reproductive potential must agree to use effective contraception from the time of informed consent until 2 years after administration of the study drug.
• Women of childbearing potential (WOCBP) include premenopausal women and those within 2 years post-menopause.
• A negative blood pregnancy test is required for all female participants of childbearing potential at screening.

You may not qualify if…

• Subjects 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): Subjects 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): Subjects with positive HCV antibodies and detectable HCV RNA should be excluded.
• Human immunodeficiency virus (HIV) antibody-positive subjects should be excluded.
• Cytomegalovirus (CMV) DNA test-positive subjects should be excluded.
• Epstein-Barr virus (EBV) DNA test-positive subjects should be excluded.

Where it is running

• Deparment of Hematology, Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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