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

November 26, 2022 updated by: Kecellitics Biotech Company Ltd

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental:3
Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Biological: Anti-CD19-CAR
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antitumor Effects
Time Frame: 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.
Every 3 months post treatment up to 24 months
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time Frame: 4 weeks
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
4 weeks
Adverse events of each patient
Time Frame: 3 years
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
Time Frame: 3 years
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kecellitics Biotech Company Ltd

Collaborators

Hebei Yanda Ludaopei Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 26, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kece-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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