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Relapsed/Refractory Aggressive B-Cell LymphomaPhase 1/2NCT07476066

Clinical Study of SYS6055 Injection in Participants With Relapsed/Refractory Aggressive B-Cell Lymphoma

A Phase 1/2 study testing SYS6055 in people with Relapsed/Refractory Aggressive B-Cell Lymphoma, run by Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This is a Phase I/II clinical study conducted in participants with relapsed/refractory aggressive B-cell lymphoma. The study aims to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6055 Injection in participants with relapsed/refractory aggressive B-cell lymphoma, and… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SYS6055
Could I receive a placebo?
No, everyone receives an active treatment
How many people
374 participants
Where
No sites listed yet
Study dates
15 Mar 2026to 15 Mar 2031
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age ≥ 18 year, and voluntarily signed the Informed Consent Form (ICF);
  • 2. Histologically confirmed aggressive B-cell lymphoma (defined according to the 5th edition of the WHO classification);
  • 3. Patients with relapsed/refractory aggressive B-cell lymphoma who failed standard therapy, with CD19-positive tumor cells;
  • 4. At least one measurable lesion according to the 2014 Lugano Response Criteria for Lymphoma;
  • 5. ECOG performance status score of 0-1;
  • 6. Expected survival of at least 3 months;
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  • 7. Adequate organ and bone marrow function;
  • 8. Eligible participants (males and females) of reproductive potential must agree to use a reliable method of contraception (hormonal contraception, barrier method, or abstinence) with their partner during the trial and for at least 1 year after dosing. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. In addition, female participants must agree not to donate oocytes (eggs, ova) for assisted reproductive technology for 1 year after dosing, and male participants must agree not to donate sperm for assisted reproductive technology for 1 year after dosing;
  • 9. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • 1. History of other malignancy within 3 years or concurrent other active malignancy (participants with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., may be enrolled);
  • 2. Participants with bleeding diathesis, active bleeding, hemoptysis, or history of major bleeding within the previous 6 months; tumor invasion of major blood vessels shown by imaging (CT or MRI), or tumor judged by the investigator as highly likely to invade major blood vessels and cause fatal massive bleeding during the subsequent study period;
  • 3. Participants with aggressive B-cell lymphoma involving the central nervous system;
  • 4. Received autologous hematopoietic stem cell transplantation within 3 months prior to the first dose;
  • 5. Previous allogeneic bone marrow transplantation, gene therapy, or adoptive cell therapy (including CAR-T therapy);
  • 6. Received anti-PD-1, anti-PD-L1, or T-cell engager therapy within 3 months prior to the first dose; received fludarabine or bendamustine within 6 months prior to the first dose;
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  • 7. Adverse events from prior antineoplastic therapy have not recovered to CTCAE Version 6.0 grade ≤1 (except for alopecia or other toxicities without safety risk as judged by the investigator);
  • 8. Received major surgery, chemotherapy, radical radiotherapy, antibody-based targeted therapy, imunotherapy, or other antineoplastic therapy within 28 days prior to dosing; or received palliative radiotherapy, chemotherapy, or small-molecule targeted therapy within 14 days prior to dosing; or received antineoplastic herbal preparations or traditional Chinese patent medicines within 14 days prior to dosing;
  • 9. Simultaneously participating in another clinical trial, unless it is an observational (non-interventional) clinical trial or in the follow-up phase of an interventional trial (without impact on the follow-up data of this study);
  • 10. Received live vaccine within 4 weeks prior to dosing;
  • 11. Active bacterial, fungal, or viral infection prior to dosing. Individuals receiving prophylactic antimicrobial therapy without clinical manifestations of active infection prior to dosing may be considered for enrollment;
  • 12. Autoimmune disease requiring systemic therapy;
  • 13. History of central nervous system disease or current persistent central nervous system disease that may interfere with neurological assessments;
  • 14. History of immunodeficiency or positive HIV antibody test during screening;
  • 15. History of tuberculosis treatment within 2 years prior to dosing; history of active syphilis;
  • 16. Active hepatitis B or hepatitis C during screening. Active hepatitis B is defined as HBsAg-positive and HBV DNA above the upper limit of normal (ULN). Active hepatitis C is defined as HCV antibody-positive and HCV RNA > ULN;
  • 17. History of severe cardiovascular disease;
  • 18. Hypersensitivity or intolerance to the excipients of SYS6055 (mainly human albumin);
  • 19.Any other conditions in participants that may interfere with compliance with study procedures, are not in the best interest of participants, or may affect study results: e.g., history of psychiatric disorders, drug addiction or substance abuse, any other clinically significant diseases or conditions, etc.;
  • 20. Pregnant or lactating female;
  • 21. Any other reason judged by the investigator that the participant is not suitable for participation in this clinical trial.

About this study

Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6055 Injection in Participants With Relapsed/Refractory Aggressive B-Cell Lymphoma

This is a Phase I/II clinical study conducted in participants with relapsed/refractory aggressive B-cell lymphoma. The study aims to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6055 Injection in participants with relapsed/refractory aggressive B-cell lymphoma, and to provide a basis for the recommended dosing regimen in subsequent studies.

Being tested
SYS6055
Medical subject headings
Recurrence

What participants receive

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

  • SYS6055Drug

    The dose will be selected based on the dose cohort, with a single administration.

Study groups in NCT07476066
Study groupRoleWhat they receive
Dose Escalation, Backfill and Cohort ExpansionExperimentalIn the dose escalation phase, participants will receive escalating doses of SYS6055. In the roll-in phase and cohort expansion phase, participants will receive selected doses of SYS6055. Participants will be administered a single dose on Day 0 of Cycle 1.
Receives: Drug: SYS6055

What is being measured

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

  1. Dose-limiting toxicities (DLTs)

    Measured: Dose-limiting toxicities (DLTs) will be assessed 28 days after the first dose.

  2. Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Measured: Up to 24 months after administration of 6055

  3. Recommended Phase 2 Dose (RP2D) or Maximum Tolerated Dose (MTD) of SYS6055

    Measured: through study completion, an average of 3 years

Secondary outcomes (16)

  1. Objective Response Rate (ORR)

    Measured: through study completion, an average of 3 years

  2. Time to Response（TTR ）

    Measured: through study completion, an average of 3 years

  3. Duration of Response (DoR)

    Measured: through study completion, an average of 3 years

  4. Progression-free survival (PFS)

    Measured: through study completion, an average of 3 years

  5. Overall Survival (OS)

    Measured: hrough study completion, an average of 3 years

  6. PK CD19-CAR copy number and CD19 CAR-T cell content of SYS6055

    The levels of CD19 CAR RNA and DNA in peripheral blood will be determined by qPCR, with the proportion of CD19 CAR-T cells assessed by flow cytometry.

    Measured: 2 years

  7. PK，CD19 CAR-T cell phenotypes

    CD19 CAR-T cell phenotypes will be analyzed by flow cytometry, including CD4/CD8 ratio, naïve cells, memory cells, and effector cells.

    Measured: 2 years

  8. PD

    Levels of cytokines in peripheral blood (IL-6, IL-10, IFN-γ, TNF-α, etc.)

    Measured: 2 years

  9. PD

    CRP

    Measured: 2 years

  10. PD

    ferritin levels

    Measured: 2 years

  11. PD

    immunoglobulin levels (IgG, IgA, IgM)

    Measured: 2 years

  12. PD

    peripheral blood lymphocyte subsets (proportion and absolute counts of T, B, and NK cells)，Lymphocyte subsets will be analyzed by flow cytometry.

    Measured: 2 years

  13. Immunogenicity,

    Incidence of anti-CD19-CAR antibodies and antiviral antibodies.

    Measured: 2 years

  14. Viral shedding

    Peripheral blood, urine, saliva, and fecal samples will be collected at predefined time points for the assessment of viral shedding.

    Measured: 2 years

  15. Replication-competent virus detection

    Peripheral blood, urine, saliva, and fecal samples will be collected at predefined time points for the assessment of viral shedding.

    Measured: 2 years

  16. Viral integration site analysis

    Peripheral blood, urine, saliva, and fecal samples will be collected at predefined time points for the assessment of viral shedding

    Measured: 2 years

Timeline

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

  1. First posted17 Mar 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion15 Mar 2029 (estimated)
  4. Study completion15 Mar 2031 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label, single-arm, dose-escalation study using a BOIN design. Four dose cohorts will be enrolled, and dose-limiting toxicities (DLTs) will be assessed after dosing in the first cycle (28 days). The Safety Monitoring Committee (SMC) will continuously review and monitor the safety of the investigational product.
Masking
None (open label)
Enrolment
374 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07476066
Sponsor's protocol ID
SYS6055-001
Status last verified
Mar 2026
First submitted
4 Mar 2026
Last updated
17 Mar 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 1/2 study testing SYS6055 in people with Relapsed/Refractory Aggressive B-Cell Lymphoma, run by Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd.

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 9 inclusion and 21 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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?

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?

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?

Dose-limiting toxicities (DLTs) (time frame: Dose-limiting toxicities (DLTs) will be assessed 28 days after the first dose.). 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 NCT07476066.

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 17 Mar 2026.

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