Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia

Kecellitics Biotech Company

Status and phase: Not yet enrolling; Phase 1

Conditions: Leukemia

Treatments: Biological: Anti-CD19-CAR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04100187

Kece-1

Details and patient eligibility

About

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.

Full description

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ Leukemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR Tcells.

Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ Leukemia

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Relapsed or refractory B cell Leukemia.
2. KPS>60.
3. Life expectancy>3 months.
4. Gender unlimited, age from 2 years to 70 years.
5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial

Exclusion criteria

1. KPS<50.
2. Patients are allergic to cytokines.
3. Uncontrolled active infection.
4. Acute or chronic GVHD.
5. Treated with T cell inhibitor.
6. Pregnancy and nursing females.
7. HIV/HBV/HCV Infection.
8. Other situations we think improper for the research.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

experimental:3

Experimental group

Description:

Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.

Treatment:

Biological: Anti-CD19-CAR