Trials Sponsors Conditions Drugs Pricing

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
+11 more secondary outcomes

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

SYS6055Drug

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

Dose Escalation and Backfill

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Institute of Hematology & Blood Diseases Hospital, China
Otherlead

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological 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

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

April 15, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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;
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (16)

Study Arms (1)

Dose Escalation and Backfill

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (16)

Study Arms (1)

Dose Escalation and Backfill

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record