Leukemia, Lymphoma
Conditions
Keywords
Leukemia, Lymphoma, CAR T
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+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. 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+ malignancies.
Interventions
BIOLOGICALAnti-CD19-CAR
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Sponsors
The First Hospital of Jilin University
Hebei Yanda Ludaopei Hospital
Beijing Doing Biomedical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma. 2. KPS\>60. 3. Life expectancy\>3 months. 4. Gender unlimited, age from 18 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. Central nervous system leukemia within 28 days. 4. Uncontrolled active infection. 5. Acute or chronic GVHD. 6. Treated with T cell inhibitor. 7. Pregnancy and nursing females. 8. HIV/HBV/HCV Infection. 9. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of each patient. | 3 years | Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival time of Anti-CD19 CAR T cells in vivo. | 3 years | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. |
| Antitumor Effects | Every 3 months post treatment up to 24 months | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. |
| Maximum tolerated dose (MTD) of CD19 targeted CAR T cells. | 4 weeks | Maximum tolerated dose (MTD) of CD19 targeted CAR T cells. |
Countries
China
Contacts
Primary Contactgai liyun, doctor
Backup Contactli gangyi
Outcome results
None listed