Autologous Hematopoietic Stem Cell Boost Study After CAR-T Therapy

NCT ID: NCT06589089

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-12-31

Brief Summary

This is a prospective, single-arm, open study to observe the efficacy and safety of the CART-SCB regimen (Clinical Regimen for the Prospective Study of Autologous Hematopoietic Stem Cell Boost for the Improvement of Bone Marrow Suppression in Patients with High-Risk Immunohematologic Toxicity Lymphoma After Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy Therapy) . After the patient has completed CAR-T therapy, if the patient has unrelieved hematologic toxicity, consider infusing a reserve of stem cells; if myelosuppression has not been significantly relieved, stem cell infusion can be performed again.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients treated with stem cell boost

If the patient continues to have unrelieved hematologic toxicity after CAR-T cell therapy, consider infusing a reserve of stem cells; If there is no significant recovery from myelosuppression, another stem cell infusion can be performed.

Group Type: EXPERIMENTAL

autologous hematopoietic stem cell

Intervention Type: DRUG

Intervention were given myelosuppression occurring that cannot be controlled with other drugs as judged by the investigators

Interventions

autologous hematopoietic stem cell

Intervention were given myelosuppression occurring that cannot be controlled with other drugs as judged by the investigators

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older and gender-neutral;
• Diagnosis of B-cell non-Hodgkin lymphoma confirmed histologically or cytologically according to World Health Organization 2016 criteria;
• Prior CAR-T cell immunotherapy;
• Patients who are at high risk according to the CAR-HEMATOTOX score prior to leukapheresis; or patients who are clinically considered potentially at high risk for hematologic toxicity following immunotherapy (including age ≥60 years; or Eastern Cooperative Oncology Group (ECOG) Performance Status≥ 2 points; or number of prior lines of therapy ≥ 2, etc.);
• Myelosuppression as determined by the investigator has occurred after CAR-T therapy;
• Have a storage of stem cell;
• Stable lymphoma disease status (final investigator-assessed efficacy CR/PR);
• Bone marrow biopsy to rule out hemophilia/infection/bone marrow infiltration;
• Adequate organ function;
• Able to provide written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule;
• Patients of childbearing potential must be willing to use highly effective contraception for the duration of the study, and for 120 days after the last dose of treatment.

Exclusion Criteria

• History of allogeneic hematopoietic stem cell transplantation;
• History of epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
• Presence of or current concurrent other malignancies within the past 2 years, with the exception of cured carcinoma in situ of the uterine cervix, non-melanoma skin cancers, and superficial bladder tumors (Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane));
• Suffering from severe cardiovascular disease: grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac ultrasound suggestive of a left ventricular ejection fraction (LVEF) <50%;
• Allergy to any investigational drug or excipient;
• Presence of any active autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allograft transplantation, or patients with prolonged and heavy use of hormones or use of other immune-modulating agents or other patients who, as assessed by the Investigator Patients who are considered to have an impact on study treatment;
• Have an active infection;
• History of uncontrolled systemic disease, including diabetes mellitus, hypertension, and acute pulmonary disease;
• Known human immunodeficiency virus (HIV) infection;
• Presence of an underlying medical condition or alcohol/substance abuse or dependence that is not conducive to the administration of study medication, or that may interfere with the interpretation of results, or that puts the patient at high risk for developing treatment complications;
• End-organ damage due to autoimmune disease (e.g., Crohns disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years, or the need for systemic immunosuppression or other systemic disease-control medications.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Weili Zhao, Doctor

Role: CONTACT

zhao.weili@yahoo.com

+862164370045 ext. 610707

Lingshuang Sheng, Doctor

Role: CONTACT

lssheng1122@163.com

+862164370045 ext. 610707

Facility Contacts

Weili Zhao

Role: primary

zwl_trial@163.com

Other Identifiers

CART-SCB

Identifier Type: -

Identifier Source: org_study_id