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

Phase 1

Not yet recruiting

• Conditions: Leukemia
• Interventions: Biological: Anti-CD19-CAR

• Registration Number: NCT04100187
• Lead Sponsor: Kecellitics Biotech Company Ltd

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

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-26
• Last Update Posted: 2022-12-01
• Study Start: 2023-02-01
• Primary Completion: 2023-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental:3	Anti-CD19-CAR	Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.

Primary Outcome Measures

Name	Time	Method
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.
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.