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

NCT04100187 | Unknown Phase 1

• 1 other identifier: Kece-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia

Keywords

CAR-T; Leukemia

Outcome Measures

Primary Outcomes (4)

• Adverse events of each patient

  Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

  3 years

• Survival time of Anti-CD19 CAR T cells in vivo

  To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.

  3 years

• Antitumor Effects

  Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

  Every 3 months post treatment up to 24 months

• Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.

  Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.

  4 weeks

Study Arms (1)

experimental:3

EXPERIMENTAL

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

Biological: Anti-CD19-CAR

Interventions

Anti-CD19-CAR BIOLOGICAL

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

experimental:3

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory B cell Leukemia.
• KPS\>60.
• Life expectancy\>3 months.
• Gender unlimited, age from 2 years to 70 years.
• CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
• Patients who have failed at least one line of a standard treatment.
• No serious mental disorder.
• 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).
• No other serious diseases(autoimmune disease, immunodeficiency etc.).
• No other tumors.
• Patients volunteer to participate in the research.
• 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

You may not qualify if:

• KPS\<50.
• Patients are allergic to cytokines.
• Uncontrolled active infection.
• Acute or chronic GVHD.
• Treated with T cell inhibitor.
• Pregnancy and nursing females.
• HIV/HBV/HCV Infection.
• Other situations we think improper for the research.

Sponsors & Collaborators

• Kecellitics Biotech Company Ltd: lead
• Hebei Yanda Ludaopei Hospital: collaborator

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Li xiangqun

  Kecellitics Biotech Company Ltd

  STUDY CHAIR

Central Study Contacts

Li xiangqun, DOCTOR

CONTACT

086-15712867910; xiangqun_li@doingtimes.com

Li xiangqun

CONTACT

086-15712867910; xiangqun_li@doingtimes.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 24, 2019
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: December 1, 2022

Record last verified: 2022-11