UnknownEarly Phase 1

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research

China36 participantsStarted 2024-05-15

Plain-language summary

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies

Age range6 Months – 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 range: 6 months to 18 years old, inclusive, for both males and females.
✓. The patient or their guardian voluntarily signed the informed consent.
✓. Patients with relapsed or refractory CD19-positive B cell hematological malignancies:
✓. Relapsed or refractory B-ALL (meeting one of the following conditions):
✓. Relapsed or refractory CD19+ B-NHL (meeting one of the following conditions):
✓. Positive CD19 expression comfirmed by immunohistochemistry or flow cytometry.
✓. For participants who had failed prior CD19-CAR T cell therapy: at least 30-days has elapsed since participant received last CD19-CAR T cell therapy.
✓. Presence at least one measurable lesion at baseline, as per the initial assessment, staging and response assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition).

✕. Patients with a history of central nervous system (CNS) diseases other than CNS leukemia, such as seizures disorders, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
✕. Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion.
✕. Patients who have participated in other clinical trials within 30 days prior to enrollment.

MTD

Timeframe: MTD will be determined based on DLTs observed during the first 28 days of study treatment

Objective response rate (ORR)

Timeframe: Within 3 months following infusion of Meta10-19

NCT IDNCT06393335

SponsorThe Children's Hospital of Zhejiang University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

Xiaojun Xu, PhD

Who can participate

Age range6 Months – 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 range: 6 months to 18 years old, inclusive, for both males and females.
✓. The patient or their guardian voluntarily signed the informed consent.
✓. Patients with relapsed or refractory CD19-positive B cell hematological malignancies:
✓. Relapsed or refractory B-ALL (meeting one of the following conditions):
✓. Relapsed or refractory CD19+ B-NHL (meeting one of the following conditions):
✓. Positive CD19 expression comfirmed by immunohistochemistry or flow cytometry.
✓. For participants who had failed prior CD19-CAR T cell therapy: at least 30-days has elapsed since participant received last CD19-CAR T cell therapy.
✓. Presence at least one measurable lesion at baseline, as per the initial assessment, staging and response assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition).

✕. Patients with a history of central nervous system (CNS) diseases other than CNS leukemia, such as seizures disorders, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
✕. Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion.
✕. Patients who have participated in other clinical trials within 30 days prior to enrollment.