Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia

July 12, 2023 updated by: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells.The safety of CAR T therapy was evaluated by observing adverse events after cell therapy;The efficacy of CAR-T therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the pharmacokinetics (PK) of CAR T cells.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • No.212 Daguan Road, Xishan District

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The diagnosis of myeloid leukemia was clear;Refractory treatment was defined as: (1) 2 patients who did not achieve partial remission after treatment with standard induced remission regimens.② The patients who relapsed within 6 months after the first remission were also called early recurrence.③ The failure relapsed 6 months after the initial response, but was retreated with the original induced response regimen.(4) multiple relapse.Relapse is defined as: patients who achieve complete remission after treatment, more than 5% of leukemia cells in the bone marrow, also known as intramedullary recurrence;Or the presence of leukaemia outside the bone marrow, also known as extramedullary relapse (usually in the central nervous system, testicular leukemia is the most common);
  2. Diseased cells were confirmed to express CD123, CLL1 and other targets;
  3. KPS > 60 points;
  4. Expected survival of more than 3 months;
  5. No gender limitation, age 2-75;
  6. Patients clinically diagnosed as high-risk type, refractory type of recurrence or not eligible for standard treatment;
  7. No serious mental disorders;
  8. Sufficient heart, liver and renal function (a. Liver function: ALT/AST < 3 times upper limit of normal value (ULN) and bilirubin ≤34.2μmol/L;B. Renal function: creatinine < 220μmol/L;C. Lung function: indoor oxygen saturation ≥95%;D. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%;);
  9. No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program;
  10. Can cooperate with trial management and follow-up;
  11. Patients voluntarily participated in the study and signed the informed consent

Exclusion Criteria:

  1. History of other malignant tumors;
  2. Uncontrolled active infection;
  3. Patients with underlying diseases requiring systemic use of glucocorticoids;
  4. Acute or chronic GVHD;
  5. T-cell inhibitor therapy;
  6. Pregnant and lactating women;
  7. Patients with active hepatitis B;
  8. Other conditions considered by the investigator to be inappropriate for the study (HIV infection, intravenous drug addiction, etc.), or other conditions that may affect the analysis of the results of the clinical study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm
CLL-1 targeting CAR-T treatment
Drug: Anti-CLL1 CART cells
In this study, patients with acute myeloid leukemia were treated with autologous anti-CLL1 CAR T cells by a single, intravenous infusion.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the efficacy of CAR T cells.
Other Names:
  • CLL1 CAR-T

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of AE after CAR-T infusion
Time Frame: up to 12 months after CAR-T infusion

Incidence of adverse events after CAR-T infusion

Data. The records of adverse events (AE) should include: description of AE and all related symptoms, occurrence time, severity, duration, measures taken, final results and outcomes. According to NCI CTC AE 5.0 standard, AE was scored

Grade.

Safety evaluation indexes include but are not limited to the following contents

  1. Any spontaneously reported and all directly observed adverse events;
  2. Any abnormal changes in vital signs and physical examination;
  3. The abnormal results of laboratory examination, physical examination and blood examination with clinical significance after treatment
up to 12 months after CAR-T infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR rate
Time Frame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
Overall response rate (ORR=CR+CRi) after CAR-T infusion
1month, 2 months, 3months, 6months ,12months after CAR-T infusion
PFS
Time Frame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
Progression free survival (PFS) after CAR-T infusion
1month, 2 months, 3months, 6months ,12months after CAR-T infusion
OS
Time Frame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
overall survival (OS) after CAR-T infusion
1month, 2 months, 3months, 6months ,12months after CAR-T infusion
Change of CAR Copies
Time Frame: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
CAR Copies measured by qPCR after CAR-T infusion
Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
Change of CAR-T cell counts
Time Frame: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
CAR-T cell counts measured by Flow cytometry after CAR-T infusion
Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BG-CT-19-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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