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B-cell Acute Lymphoblastic LeukemiaNCT06389305

CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction

A study testing peripheral blood lymphocytes and CIK cell in people with B-cell Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK… Read more about this study

Who is it for?
Ages 1 year to 39 years
What is being tested?
peripheral blood lymphocytes and CIK cell
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
213 participants
Where
1 siteChina
Study dates
27 May 2024to 30 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • A patient must meet all of the following to be enrolled:
  • A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer Network(NCCN) guidelines for the diagnosis of acute lymphoblastic leukemia (hematopathological examination of bone marrow aspirate and biopsy tissue showing ≥20% lymphoblasts in the bone marrow, confirmed by comprehensive flow cytometry (FCM) immunotyping, minimal residual disease analysis, and G-banded metaphase chromosome karyotype analysis). Molecular characteristics can be described through methods such as interphase fluorescence in situ hybridization (FISH) testing, reverse transcription polymerase chain reaction (RT-PCR) testing, and next-generation sequencing (NGS) for comprehensive detection of fusion genes and pathogenic mutations. Determination can also be made by the World Health Organization's subtypes of acute lymphoblastic leukemia, as well as cytogenetic and clinical risk groups.
  • Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.
  • Age between 1 and 39 years old.
  • No severe allergic constitution.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Life expectancy, as judged by the investigator, of at least 60 days.
  • Patients with self-awareness between 8 and 39 years of age voluntarily sign an informed consent, and the legal representative (guardians) of child patients under 18 years of age voluntarily signs an informed consent.

Who cannot join

  • A patient with at least one of the following conditions will be excluded:
  • Received bendamustine treatment within the past 9 months;
  • Intracranial hypertension or impaired consciousness in the brain;
  • Symptomatic heart failure or severe arrhythmia;
  • Symptoms of severe respiratory failure;
  • With other types of malignant tumors;
Show all 17Show fewer
  • Disseminated intravascular coagulation;
  • Serum creatinine and/or blood urea nitrogen ≥ 1.5 times the normal value;
  • Suffering from sepsis or other uncontrollable infections;
  • Uncontrollable diabetes;
  • Severe mental disorders;
  • Significant lesions in the brain as detected by head magnetic resonance imaging;
  • Leukemic cells in the cerebrospinal fluid >20 cells/μL;
  • Peripheral blood leukemic cell proportion >30%;
  • Have undergone organ transplantation;
  • Female patients (those with childbearing potential) are pregnant or lactating;
  • Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tengyu Wang contact

86+18333186020

tengyu.wang@gohealtharo.com

China1 site, 1 recruiting

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 102206

    Tengyu Wang, 86+18333186020, tengyu.wang@gohealtharo.com

    Recruiting

Other trials in China

About this study

Official title: Cytokine-induced Killer(CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-T(CAR-T) Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study

This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.

Being tested
peripheral blood lymphocytes, CIK cell
Medical subject headings
Burkitt Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peripheral blood lymphocytesDrug

    autologous or allogeneic peripheral blood lymphocytes

  • CIK cellDrug

    autologous or allogeneic cytokine-induced killer (CIK) cells

Study groups in NCT06389305
Study groupRoleWhat they receive
peripheral blood lymphocytesPlacebo comparatorNot described
Receives: Drug: peripheral blood lymphocytes
CIK cellsExperimentalNot described
Receives: Drug: CIK cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival(EFS) in CIK infusion group

    EFS is defined as the time from CIK-cell infusion to the earliest relapse, death from any cause, or treatment failure

    Measured: 2-year EFS rate

Secondary outcomes (4)

  1. Progression-free survival(PFS) in CIK infusion group

    PFS is defined as the time from CIK-cell infusion until objective tumor progression or death depending on study protocol

    Measured: 2-year PFS rate

  2. Duration of response(DOR) in CIK infusion group

    DOR is defined as the time interval from the earliest qualifying minimal residual disease-negative response [i.e. complete remission(CR),complete remission with partial hematological recovery(CRh), complete remission with incomplete hematological recovery(CRi), morphologic leukemia-free state(MLFS), or aplastic marrow (patients with blood and bone marrow disease), central nervous system(CNS) remission (patients with CNS disease) and complete resolution of the lymphomatous enlargement by CT or positron emission tomography(PET)-CT negative (for patients with a previous positive PET-CT) (patients with lymphomatous extramedullary disease)] to the date of relapse or death from any cause.

    Measured: from enrollment to the end of treatment at 15 years

  3. Overall survival(OS) in CIK infusion group

    OS is defined as the time from CIK-cell infusion to death from any cause.

    Measured: from enrollment to the end of treatment at 15 years

  4. EFS in mRNA-CIK infusion group

    EFS is defined as the time from mRNA-CIK-cell infusion to the earliest relapse, death from any cause, or treatment failure

    Measured: 2-year EFS rate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start27 May 2024
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
a prospective cohort study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
213 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06389305
Sponsor's protocol ID
BJGBYY-IIT-LCYJ-2024-012
Status last verified
Feb 2026
First submitted
24 Apr 2024
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing peripheral blood lymphocytes and CIK cell in people with B-cell Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tengyu Wang (86+18333186020, tengyu.wang@gohealtharo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival(EFS) in CIK infusion group (time frame: 2-year EFS rate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06389305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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