A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 65
Healthy Volunteers: f
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⁃ The subject or their legally authorized representative (guardian) understands the study and voluntarily signs the informed consent form (ICF).

⁃ Male or female, aged 3 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.

⁃ 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.

Locations
Other Locations
China
Deparment of Hematology, Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
MENG LV, MD, PhD
drlvmeng@bjmu.edu.cn
+861088324637
Time Frame
Start Date: 2024-11-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: CD19/CD22 Tandem Dual CAR-T
Eligible patients will be treated with Nanobody-Based CD19/CD22 Tandem Dual CAR-T
Sponsors
Collaborators: Hebei Senlang Biotechnology Inc., Ltd.
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov