Clinical trial NCT04100187: Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia
Official title: Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leukemia
Keywords: CAR-T
Leukemia
Lead sponsor: Kecellitics Biotech Company Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hebei Yanda Ludaopei Hospital
First posted: 2019-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events of each patient
timeFrame: 3 years
measure: Survival time of Anti-CD19 CAR T cells in vivo
timeFrame: 3 years
measure: Antitumor Effects
timeFrame: Every 3 months post treatment up to 24 months
measure: Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kecellitics Biotech Company Ltd
name: Li xiangqun
role: STUDY_CHAIR
References: