This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed CD19+ haematological malignancies.
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) γδT-cells (CD19 CAR γδT-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR γδT-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR γδT-cells in patients with high risk relapsed CD19+ malignancies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
Beijing DOING Biomedical Co., Ltd
Beijing, China
Adverse events of each patient.
Adverse events of each patient will be recorded and analysed.
Time frame: 3 years
Survival time of Anti-CD19 CAR γδT cells in vivo.
PCR will be applied to analyse the survival time of Anti-CD19 CAR γδT cells in vivo.
Time frame: 3 years
Antitumor Effects
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time frame: Every 3 months post treatment up to 24 months
Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.
Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.