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

NCT ID: NCT04100187

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-08-01

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

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental:3

Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.

Group Type: EXPERIMENTAL

Anti-CD19-CAR

Intervention Type: BIOLOGICAL

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

Interventions

Anti-CD19-CAR

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role: collaborator

Kecellitics Biotech Company Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li xiangqun

Role: STUDY_CHAIR

Kecellitics Biotech Company Ltd

Central Contacts

Li xiangqun, DOCTOR

Role: CONTACT

xiangqun_li@doingtimes.com

086-15712867910

Li xiangqun

Role: CONTACT

xiangqun_li@doingtimes.com

086-15712867910

Other Identifiers

Kece-1

Identifier Type: -

Identifier Source: org_study_id