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Relapsed/Refractory B-cell Non-Hodgkin's LymphomaPhase 2NCT05312476

Clinical Study on CAR-T Targeting Igβ Targets in Refractory Relapsed Non-Hodgkin's Lymphoma

A Phase 2 study testing Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets in people with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive refractory relapsed non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
26 May 2026to 28 May 2026
Phase
Phase 2
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 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Voluntary signing of informed consent and good compliance.
  • Age ≥ 6 years.
  • Previously treated with 2 or more lines of therapy.
  • Has a measurable target lesion.
  • ECOG 0-1#.
  • Have appropriate organ function, subject to the following criteria (except for abnormal liver function due to tumor infiltration): AST≤3 times upper limit of normal#ALT≤3 times upper limit of normal# TB≤2 times ULN, unless combined with Gilbert's syndrome #Patients with Gilbert's syndrome with TB≤ 3 times ULN and DB≤ 1.5 times ULN can be include # Scr ≤1.5 times ULN or CCr≥60 ml/min# Lung function≤Level 1; dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption> 91%# INR≤1.5 times ULN# aPTT≤1.5 times ULN.
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  • negative blood/urine pregnancy test in women of childbearing age within 7 days prior to cell infusion, and any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least six months after the study treatment is administered.
  • Pass the T-cell amplification test.
  • Have adequate venous access to single or venous blood and no other contraindications to leukocyte isolation.
  • Estimated survival time ≥3 months.

Who cannot join

  • Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma), except for cured malignant tumors with no active lesions for 3 years; Adequate treatment of inactive lesions in non-melanoma skin cancer, malignant tonsilloma or carcinoma in situ.
  • Have used immunosuppressants or hormones within 2 weeks prior to signing informed consent, or plan to have to use immunosuppressants or high-dose hormones (e.g. prednisone >15mg) after signing informed consent, specifically systemic treatment, excluding treatment with topical or inhaled corticosteroids.
  • The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
  • HIV, Syphilis or COVID-19 infection.
  • Active hepatitis B or active hepatitis C.
  • Previous or current CNS disease other than this disease, such as seizures, cerebrovascular ischaemia/hemorrhage, dementia, cerebellar disease or any CNS-related autoimmune disease.
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  • A history of cardiac angioplasty or stent placement within 12 months prior to signing the informed consent form, or a history of myocardial infarction, unstable angina or other clinically significant heart disease.
  • Patients with primary immunodeficiency.
  • Have had a severe tachyphylaxis to any of the drugs to be used in this study.
  • Live vaccination within 6 weeks prior to screening.
  • Pregnant or breasting-feeding women.
  • Active autoimmune diseases.
  • Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form.
  • Received an allogeneic hematopoietic stem cell transplant within 6 months prior to signing the informed consent form.
  • Participated in an investigational clinical trial of any other drug within 30 days prior to signing the informed consent form.
  • Conditions deemed by the researcher to be inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: Clinical Study of the Safety, Tolerability and Preliminary Efficacy of Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets in Patients With Igβ-positive Refractory Relapsed Non-Hodgkin's Lymphoma

Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive refractory relapsed non-Hodgkin's lymphoma.

Read the detailed description

Non-Hodgkin's lymphoma is a group of malignant neoplasms of the lymphatic system originating from B or T cells, of which 60-70% of patients have B-cell-derived lymphoma (B-NHL). Although rituximab in combination with chemotherapy has significantly improved the prognosis of B-cell lymphoma, some patients still have primary resistance or relapse. In recent years, breakthroughs have been made in the treatment of B-cell tumors with Chimeric Antigen Receptor-Modified T Cells (CART), the investigators therefore constructed CAR-T cells targeting Igβ to investigate the safety and efficacy of CAR-T cells with this target for the treatment of r/r B-NHL.

Being tested
Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets
Keywords
CAR-T Cells targeting Igβ targets, Relapsed Refractory B-cell Non-Hodgkin's Lymphoma
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ TargetsDrug

    Also called Chimeric antigen receptor-modified T (CAR-T) cell therapy

    1. Dose escalation studies:3 dose groups in total: expect 3-6 cases in each group, and dose set at 1×106/kg，3×106/kg，6×106/kg.
    2. Dose extension study:3 cases (1 dose group).
Study groups in NCT05312476
Study groupRoleWhat they receive
Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ TargetsExperimentalChimeric antigen receptor T cells targeting Igβ targets (CAR-T)
Receives: Drug: Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets

What is being measured

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

  1. DLT

    DLT occurring within 28 days of the last dose.

    Measured: Measured from start of treatment until 28 days after last dose

  2. Adverse events profile

    Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.

    Measured: Measured from start of treatment until 28 days after last dose

Secondary outcomes (8)

  1. Objective Response Rate

    Proportion of CR and PR subjects will be assessed at 3 months post-infusion.

    Measured: up to 3 months

  2. Duration of Response

    Duration of overall response will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to progression, death or last follow-up.

    Measured: up to 12 months

  3. Progression-free survival

    To measure the duration of response to chimeric antigen receptor T cells (CAR-T) targeting Igβ targets over a follow-up period of 12 months.

    Measured: up to 12 months

  4. Overall Survival

    OS will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to death or last follow-up.

    Measured: up to 12 months

  5. Peak Plasma Concentration

    the peak amplification of Igβ-CART in peripheral blood.

    Measured: Measured from start of treatment until 28 days after last dose

  6. Time to Peak Amplification

    the time to peak amplification of Igβ-CART in peripheral blood.

    Measured: Measured from start of treatment until 28 days after last dose

  7. AUC0-28

    the area under the curve (AUC0-28) obtained by plotting the number of CAR-T cells in serum against the visit time from 0 to 28 days after reinfusion.

    Measured: Measured from start of treatment until 28 days after last dose

  8. PD

    Pharmacodynamics is the peripheral blood B-cell ratio.

    Measured: Measured from start of treatment until 28 days after last dose

Timeline

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

  1. First posted5 Apr 2022
  2. Study start26 May 2026 (estimated)
  3. Primary completion28 May 2026 (estimated)
  4. Study completion28 May 2026 (estimated)

Why it stopped: The study did not initiate because manufacturing of the CAR-T product failed.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312476
Sponsor's protocol ID
R/R B-NHL 02
Status last verified
May 2026
First submitted
21 Mar 2022
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets in people with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, run by The First Affiliated Hospital of Soochow University 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 10 inclusion and 16 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: withdrawn, as of the sponsor's last update on 3 Jun 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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?

DLT (time frame: Measured from start of treatment until 28 days after last dose). The study lists 2 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 NCT05312476.

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 2026.

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