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Phase I Clinical Study to Evaluate SYS6055 Injection in Participants With Relapsed/Refractory B-Cell Malignancies Phase I 86

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07493174 est conçu pour étudier le traitement de Maladies malignes à cellules B en rechute/réfractaires. Il s'agit d'une étude interventionnel en Phase I. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 15 avril 2026, avec un objectif de 86 participants. Dirigée par Institute of Hematology & Blood Diseases Hospital, China, l'étude devrait être terminée d'ici le 15 avril 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 mars 2026.
Résumé succinct
(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.
Description détaillée
(Limit: 32,000 characters)
Titre officiel

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6055 Injection in Participants With Relapsed/Refractory B-Cell Malignancies

Pathologies
Maladies malignes à cellules B en rechute/réfractaires
Autres identifiants de l'étude
  • IIT2026024
Numéro NCT
NCT07493174
Date de début (réel)
2026-04-15
Dernière mise à jour publiée
2026-03-25
Date de fin (estimée)
2030-04-15
Inscription (estimée)
86
Type d'étude
Interventionnel
PHASE
Phase I
Statut
Pas encore en recrutement
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalDose Escalation and Backfill
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.
SYS6055
The dose will be selected based on the dose cohort, with a single administration.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
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.
2 years
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.
2 years
PD
Levels of cytokines in peripheral blood (IL-6, IL-10, IFN-γ, TNF-α, etc.).
2 years
PD
CRP
2 years
PD
ferritin levels
2 years
PD
immunoglobulin levels (IgG, IgA, IgM)
2 years
PD
peripheral blood lymphocyte subsets (proportion and absolute counts of T, B, and NK cells)，Lymphocyte subsets will be analyzed by flow cytometry.
2 years
Immunogenicity
Incidence of anti-CD19-CAR antibodies and antiviral antibodies.
2 years
Viral shedding
Peripheral blood, urine, saliva, and fecal samples will be collected at predefined time points for the assessment of viral shedding.
2 years
Replication-competent virus detection
Peripheral blood, urine, saliva, and fecal samples will be collected at predefined time points for the assessment of viral shedding.
2 years
Viral integration site analysis
Peripheral blood, urine, saliva, and fecal samples will be collected at predefined time points for the assessment of viral shedding.
2 years
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 1. Age≥18 year, and voluntarily signed the Informed Consent Form (ICF); 2. Histologically confirmed B-cell malignancy with CD19 antigen-positive tumor cells; 3. Patients with relapsed/refractory B-cell malignancies who have failed standard therapy, including B-cell leukemia and B-cell lymphoma; 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; 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.

  • 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 B-cell malignancies 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; 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.
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