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Acute Lymphocytic LeukemiaPhase 1NCT05292898

A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia

A Phase 1 study testing LCAR-AIO Cells in people with Acute Lymphocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell acute lymphocytic leukemia Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Lymphocytic Leukemia
What is being tested?
LCAR-AIO Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesChina
Study dates
14 Mar 2022to 31 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
  • Age 18-75 years;
  • ECOG score: 0-1;
  • Detect the expression of at least one of CD19/CD20/CD22 in leukemic cells by Flow cytometry in peripheral blood or bone marrow
  • Leukemia cells in the bone marrow >5%
  • Pathologically confirmed relapsed/refractory ALL must meet one of the following conditions:
Show all 12Show fewer
  • Naive patients who failed to achieve CR1 after standard chemotherapy;
  • relapse within 12 months after CR1, or relapse after 12 months but fail to achieve CR2
  • twice or more bone marrow relapse
  • Philadelphia chromosomal positive (Ph+) and unable to tolerate TKI therapy, failed TKI therapy more than 2 lines, or had contraindications for TKI therapy
  • Clinical laboratory values meet screening visit criteria
  • Expected survival ≥ 3 months;

Who cannot join

  • 1.Prior antitumor therapy with insufficient washout period; 2.CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission; 3.Have received two or more targets (CD19/CD20/CD22) CAR-T cell therapy (including but not limited to sequential infusion) at any previous time, or have received CAR-T cell therapy from Camel family origin; 4.With acute or chronic graft-versus-host disease; 5.Isolated extramedullary relapse, but hepatic, spleen, or lymph node-isolated extramedullary relapse is acceptable; 6.HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 7.Pregnant or lactating women;
  • -

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Gobroad BoRen Hospital

    Beijing, Beijing Municipality

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-AIO, a Triple-targeted Cell Preparation Targeting CD19/CD20/CD22, in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell acute lymphocytic leukemia

Read the detailed description

This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of LCAR-AIO in patients ≥ 18 years of age with relapsed or refractory B-cell acute lymphocytic leukemia. Patients who meet the eligibility criteria will receive a single dose of LCAR-AIO infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.

Being tested
LCAR-AIO Cells
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • LCAR-AIO CellsBiological

    LCAR-AIO Cells before treatment with LCAR-AIO cells, subjects will receive a conditioning regimen (IV infusion of cyclophosphamide 300 mg/m^2 and fludarabine 30mg/m^2 once daily (QD) for 3 days.

Study groups in NCT05292898
Study groupRoleWhat they receive
LCAR-AIO CellsExperimentalEach subject will be treated with LCAR-AIO Cells
Receives: Biological: LCAR-AIO Cells

What is being measured

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

  1. Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

    An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

    Measured: [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

  2. Recommended Phase 2 dose (RP2D) finding

    RP2D established through ATD+BOIN design

    Measured: [Time Frame: 30 days after LCAR-AIO infusion (Day 1)]

  3. CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow

    CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow after LCAR-AIO infusion

    Measured: [Time Frame: 2 years after LCAR-AIO infusion (Day 1)]

Secondary outcomes (6)

  1. Overall response rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or CRi after treatment via LCAR-AIO cell infusion

    Measured: [Time Frame: 90 days after LCAR-AIO infusion (Day 1)]

  2. Time to Response (TTR)

    Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-AIO to the date of the first response evaluation of the subject who has met all criteria for CR or CRi.

    Measured: [Time Frame: 90 days after LCAR-AIO infusion (Day 1)]

  3. Duration of Response (DoR)

    Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or CRi) to the first documented relapse evidence of the responders

    Measured: [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

  4. Relapse-free survival (RFS)

    Relapse-free survival (RFS) is defined as the time from the date of first infusion of the LCAR-AIO to the first documented disease relapse or death (due to any cause), whichever occurs first

    Measured: [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

  5. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AIO to death of the subject

    Measured: [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

  6. Incidence of anti-LCAR-AIO antibody and positive sample titer

    Venous blood samples will be collected to measure LCAR-AIO positive cell concentrations and the transgenic level of LCAR-H93T, at the time points when anti-LCAR-AIO antibody serum samples are evaluated

    Measured: [Time Frame: Minimum 2 years after LCAR-H93T infusion (Day 1)]

Timeline

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

  1. First posted23 Mar 2022
  2. Study start14 Mar 2022
  3. Primary completion10 Jan 2025
  4. Study completion31 Mar 2025

Why it stopped: Achieve the proof of concept

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292898
Sponsor's protocol ID
IIT2021065
Status last verified
Dec 2024
First submitted
14 Mar 2022
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LCAR-AIO Cells in people with Acute Lymphocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites 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 12 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Achieve the proof of concept). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]). The study lists 3 primary outcomes in all. 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 NCT05292898.

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 3 Jun 2025.

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