Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relap… (NCT06277011) | Clinical Trial Compass
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
China18 participantsStarted 2023-02-10
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
Who can participate
Age range3 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The patient or his/her guardian voluntarily signed the informed consent.
✓. Meeting one of the following conditions:
✓. Patients with relapsed or refractory B-cell lymphoma who have received CD20 antibodies (such as rituximab) and at least two chemotherapy treatments, one of which should include anthracyclines. After these regimens, patients maintained SD (SD duration ≤12 months) or disease progression.
✓. Partial remission (PR) or minimal residual lesions after two chemotherapy treatments.
✓. Recurrence after autologous hematopoietic stem cell transplantation.
✓. Extramedullary recurrence or residual leukemia cells ≥ 0.01% in bone marrow after allogeneic hematopoietic stem cell transplantation.
✓. Patients with relapsed or refractory B-ALL who not suitable for hematopoietic stem cell transplantation.
✓. CD19 expression was positive by immunohistochemistry or flow cytometry (\>30%)，accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection.
Exclusion criteria
✕. Patients with present or history of central nervous system diseases such as seizures disorder, 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.
What they're measuring
1
MTD
Timeframe: MTD will be determined based on DLTs observed during the first 28 days of study treatment
2
Objective response rate (ORR)
Timeframe: Within 3 months following infusion of Meta10- 19
✕. Patients who participated in other clinical trials within 30 days prior to enrollment.
✕. Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \>1000 copies/ml) or hepatitis C (HCV RNA positive).
✕. Patients with HIV antibody positive or treponema pallidum antibody positive.
✕. Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19 infusion).
✕. Patients with unstable angina pectoris and/or myocardial infarction within 6 months prior to enrollment.
✕. Patients with history of other malignancies, but the following conditions can be enrollment: