Not Yet RecruitingEarly Phase 1

The Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed/Refractory Acute T-lymphoblastic Leukemia

9 participantsStarted 2025-07

Plain-language summary

To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children.

Age range2 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥2 and ≤18 years old, male or female;
✓. Subjects who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) according to the standards of the NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2024.V6);
✓. Meets the criteria for recurrent or refractory T-ALL, including: a) Recurrent: Reappearance of blasts in peripheral blood or bone marrow (\>25%) after complete remission or occurrence of extramedullary disease, and ineffectiveness of other treatments； b) Primary Refractory: Appearance of blasts in bone marrow ≥5% after 2 months standard induction chemotherapy, and no other treatment can be used as judged by the investigator;
✓. After one cycle of other treatments (such as Olverembatinib combined with APG-125), the blasts remain≥5%;
✓. Cell immunophenotyping confirmation of CD7 positive blasts \>80%;
✓. Estimated survival period \>12 weeks;
✓. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 or KPS \> 60;
✓. Left ventricular ejection fraction ≥50%;

✕. Extramedullary involvement of the central nervous system or testicular at screening.
✕. Patients with a history of severe CNS diseases, such as uncontrolled seizures, stroke, severe brain damage resulting in speech impairment, psychiatric disorders, etc;
✕. NYHA functional class III or IV heart failure;
✕. Presence of disseminated intravascular coagulation;
✕. Presence of severe autoimmune diseases or immune deficiency diseases;
✕. Active GVHD requiring systemic treatment;
✕. Presence of other severe diseases, presence of gastrointestinal ulcers or active gastrointestinal bleeding, currently undergoing anticoagulant or antiplatelet therapy, or judged by the investigator to pose unacceptable surgical or anesthesia risks;
✕. Currently receiving systemic steroids or other immunosuppressive therapy prior to screening, and still need long-term use after enrollment as judged by the investigator (excluding inhaled or local use);

Incidence and severity of adverse events

Timeframe: 1 year post the first VGO-Cs01p infusion

NCT IDNCT06849401

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Hui Zhang

Who can participate

Age range2 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥2 and ≤18 years old, male or female;
✓. Subjects who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) according to the standards of the NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2024.V6);
✓. Meets the criteria for recurrent or refractory T-ALL, including: a) Recurrent: Reappearance of blasts in peripheral blood or bone marrow (\>25%) after complete remission or occurrence of extramedullary disease, and ineffectiveness of other treatments； b) Primary Refractory: Appearance of blasts in bone marrow ≥5% after 2 months standard induction chemotherapy, and no other treatment can be used as judged by the investigator;
✓. After one cycle of other treatments (such as Olverembatinib combined with APG-125), the blasts remain≥5%;
✓. Cell immunophenotyping confirmation of CD7 positive blasts \>80%;
✓. Estimated survival period \>12 weeks;
✓. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 or KPS \> 60;
✓. Left ventricular ejection fraction ≥50%;

✕. Extramedullary involvement of the central nervous system or testicular at screening.
✕. Patients with a history of severe CNS diseases, such as uncontrolled seizures, stroke, severe brain damage resulting in speech impairment, psychiatric disorders, etc;
✕. NYHA functional class III or IV heart failure;
✕. Presence of disseminated intravascular coagulation;
✕. Presence of severe autoimmune diseases or immune deficiency diseases;
✕. Active GVHD requiring systemic treatment;
✕. Presence of other severe diseases, presence of gastrointestinal ulcers or active gastrointestinal bleeding, currently undergoing anticoagulant or antiplatelet therapy, or judged by the investigator to pose unacceptable surgical or anesthesia risks;
✕. Currently receiving systemic steroids or other immunosuppressive therapy prior to screening, and still need long-term use after enrollment as judged by the investigator (excluding inhaled or local use);