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

Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Leukemia

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04100187

Enrollment

100

Registered

2019-09-24

Start date

2023-02-01

Completion date

2024-08-01

Last updated

2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

CAR-T, Leukemia

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

Interventions

BIOLOGICALAnti-CD19-CAR

Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 70 Years

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.

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.
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.

Contacts

Primary ContactLi xiangqun, DOCTOR

xiangqun_li@doingtimes.com086-15712867910

Backup ContactLi xiangqun