Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Collaborators: Hrain Biotechnology Co., Ltd.; Second Affiliated Hospital of Nanchang University
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• 5 Years to 70 Years, Male and female;

• Expected survival > 12 weeks;

• Performance score 0-2;

• Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy

• Creatinine < 2.5 mg/dl;

• ALT/AST < 3x normal;

• Bilirubin < 2.0 mg/dl;

• Adequate venous access for apheresis, and no other contraindications for leukapheresis;

• Take contraceptive measures before recruit to this trial;

• Written voluntary informed consent is given.

Exclusion Criteria:

• Patients with symptoms of central nervous system

• Accompanied by other malignant tumor

• Active hepatitis B or C, HIV infection

• Any other diseases could affect the outcome of this trial

• Suffering severe cardiovascular or respiratory disease

• Poorly controlled hypertension

• A history of mental illness and poorly controlled

• Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration

• Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment

• Reaching a steady dose if receiving anticoagulant therapy before assignment

• Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion

• Pregnant or lactating women

• Subject suffering disease affects the understanding of informed consent or comply with study protocol.