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Clinical study on the application of single-cell sequencing and TCR repertoire analysis in predicting the efficacy of CD3CD19 bispecific antibody therapy in B-ALL patients

Clinical study on the application of single-cell sequencing and TCR repertoire analysis in predicting the efficacy of CD3CD19 bispecific antibody therapy in B-ALL patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092520
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell acute lymphoblastic leukemia,B-ALL

Interventions

Trail group:no

Sponsors

HenanCancerHospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) According to the WHO diagnostic criteria, patients diagnosed with B-ALL (leukemia cells >= 20% in newly diagnosed patients, leukemia cells >= 5% in relapsed and refractory patients, or patients with CR but positive MRD) through MICM testing; Leukemia cells >= 50% indicate high burden, while Leukemia cells = 15 years old, and there is no age limit for relapsed and refractory patients; 3) The patient was treated with CD3CD19 bispecific antibodies; 4) Fully understand and voluntarily sign a written informed consent form (ICF); 5) ECOG score 0-3 scores; 6) Expected survival time >= 3 months; 7) Liver function: Total bilirubin = 30mL/min; 9) Patients who sign the informed consent form must have the ability to understand and be willing to participate in this study, and must also sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) T cell ALL; 2) MRD negative B cell ALL; 3) Mature B-cell leukemia/lymphoma, B-lymphocyte lymphoma, isolated extramedullary diseases; 4) Acute mixed cell leukemia; 5) Combined central nervous system leukemia; 6) HIV infection, positive HBV-DNA or HCV-RNA; 7) Patients with heart failure level 2 or above and those deemed unsuitable for inclusion by other researchers; 8) Pregnant, lactating, or female patients who have fertility but have not taken contraceptive measures; 9) Individuals with uncontrollable neurological, psychiatric, psychiatric, or cognitive impairments may limit their understanding, execution, and compliance with informed consent forms.

Design outcomes

Primary

MeasureTime frame
Transcriptome and TCR repertoire of CD3+T cells;

Countries

China

Contacts

Public ContactQingsong Yin

HenanCancerHospital

jnyinqingsong@163.com+86 371 65587358

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026