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B-cell Lymphoma RecurrentPhase 1NCT05318963

Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma

A Phase 1 study testing LCAR-AIO cells product in people with B-cell Lymphoma Recurrent and B-cell Lymphoma Refractory, 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 lymphoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
LCAR-AIO cells product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 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.
  • Aged 18-75 years (inclusive).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically confirmed B-cell lymphoma that expresses at least one of CD19/CD20/CD22.
  • At least one measurable tumor lesion determined according to Lugano 2014 criteria.
  • Response to prior therapy is consistent with one of the following:
Show all 12Show fewer
  • Primary refractory: it means that the best response to first-line therapy (at least 2 cycles) is PD, or best response to first-line therapy (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;
  • Relapsed or refractory after 2 or more lines of therapy. Refractory is defined that best respond to the most recent treatment regimen (at least 2 cycles) is PD, or best response to the most recent treatment regimen (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;
  • Progression or relapse within 12 months after hematopoietic stem cell transplantation; if salvage therapy is applied after transplantation, the patient must be unresponsive or relapsed to the last line of therapy;
  • Life expectancy≥ 3 months
  • Clinical laboratory values meet screening visit criteria
  • Adequate organ function;

Who cannot join

  • Subject eligible for this study must not meet any of the following criteria:
  • Prior antitumor therapy with insufficient washout period ;
  • Patients who received dual-targeted CAR-T cell therapy (including but not limited to sequential infusion) at any time in the past, or who received CAR-T cell therapy of cameloid origin;
  • With acute or chronic graft-versus-host disease (GvHD);
  • Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
  • Known life-threatening allergies, hypersensitivity, or intolerance to LCAR-AIO CAR-T cell or its excipients, including DMSO (refer to Investigator's Brochure).
  • 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, 300020

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 Lymphoma

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 lymphoma.

Read the detailed description

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LCAR-AIO in the patient ≥ 18 years of age with relapsed or refractory B cell lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LCAR-AIO injection. 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 product

What participants receive

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

  • LCAR-AIO cells productBiological

    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 NCT05318963
Study groupRoleWhat they receive
LCAR-AIO cells productExperimentalEach subject will be given a single-dose LCAR-AIO cells infusion at each dose level.
Receives: Biological: LCAR-AIO cells product

What is being measured

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

  1. Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Minimum 2 years after LCAR-AIO infusion (Day 1)

  2. Pharmacokinetics in peripheral blood

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

    Measured: Minimum 2 years after LCAR-AIO infusion (Day 1)

  3. Pharmacokinetics in bone marrow

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

    Measured: Minimum 2 years after LCAR-AIO infusion (Day 1)

  4. The recommended Phase II dose (RP2D) for this cell therapy

    RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion

    Measured: 30 days after LCAR-AIO infusion

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

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

    Measured: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

  2. Progression-free survival (PFS)

    Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-AIO to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first

    Measured: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

  3. 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: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

  4. 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 PR.

    Measured: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

  5. Duration of Response (DoR)

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

    Measured: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

  6. Immunogenicity assessment of LCAR-AIO cells

    The incidence of Anti-LCAR-AIO antibody in patients who received LCAR-AIO cells infusion

    Measured: Through study completion, minimum 2 years after LCAR-AIO 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 posted8 Apr 2022
  2. Study start14 Mar 2022
  3. Primary completion17 Jan 2025
  4. Study completion31 Mar 2025

Why it stopped: The collaborators decided to terminate this study.

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318963
Sponsor's protocol ID
IIT2021066
Status last verified
May 2025
First submitted
15 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 product in people with B-cell Lymphoma Recurrent and B-cell Lymphoma Refractory, 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 7 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: The collaborators decided to terminate this study.). 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 TEAEs (Treatment-emergent Adverse Events) (time frame: Minimum 2 years after LCAR-AIO infusion (Day 1)). The study lists 4 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 NCT05318963.

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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