Phase I Clinical Study to Evaluate SYS6055 Injection in Participants With Relapsed/Refractory B-Cell Malignancies

NCT07493174 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2026024
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

(Limit: 5000 characters) The purpose of this phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6055 Injection in participants with relapsed/refractory B-cell malignancies, and to provide evidence for recommending a dosage regimen for subsequent studies.

Conditions

Relapsed/Refractory B-Cell Malignancies

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicities (DLTs)

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

• Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)

  Up to 24 months after administration of 6055

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

  through study completion, an average of 3 years

Secondary Outcomes (16)

• Objective Response Rate (ORR)

  through study completion, an average of 3 years

• Time to Response（TTR）

  through study completion, an average of 3 years

• Duration of Response (DoR)

  through study completion, an average of 3 years

• Progression-free survival (PFS)

  through study completion, an average of 3 years

• Overall Survival (OS)

  through study completion, an average of 3 years

Study Arms (1)

Dose Escalation and Backfill

EXPERIMENTAL

In the dose escalation phase, participants will receive escalating doses of SYS6055. During the backfill phase, participants will receive selected doses of SYS6055. Participants will be administered a single dose on Day 0 of Cycle 1.

Drug: SYS6055

Interventions

SYS6055 DRUG

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

Dose Escalation and Backfill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 year, and voluntarily signed the Informed Consent Form (ICF);
• Histologically confirmed B-cell malignancy with CD19 antigen-positive tumor cells;
• Patients with relapsed/refractory B-cell malignancies who have failed standard therapy, including B-cell leukemia and B-cell lymphoma;
• At least one measurable lesion according to the 2014 Lugano Response Criteria for Lymphoma;
• ECOG performance status score of 0-1;
• Expected survival of at least 3 months;
• Adequate organ and bone marrow function;
• 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;
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• 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);
• 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;
• Participants with B-cell malignancies involving the central nervous system;
• Received autologous hematopoietic stem cell transplantation within 3 months prior to the first dose;
• Previous allogeneic bone marrow transplantation, gene therapy, or adoptive cell therapy (including CAR-T therapy);
• 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;
• 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);
• 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;
• 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);
• Received live vaccine within 4 weeks prior to dosing;
• 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;
• Autoimmune disease requiring systemic therapy;
• History of central nervous system disease or current persistent central nervous system disease that may interfere with neurological assessments;
• History of immunodeficiency or positive HIV antibody test during screening;
• History of tuberculosis treatment within 2 years prior to dosing; history of active syphilis;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-arm, dose-escalation study using an accelerated titration design combined with a traditional 3+3 design. Six dose cohorts are enrolled, and dose-limiting toxicities (DLTs) are assessed after dosing in Cycle 1 (28 days). The Safety Monitoring Committee (SMC) continuously reviews and monitors the safety of the investigational product.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): April 15, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04