Clinical trial NCT06589089: Autologous Hematopoietic Stem Cell Boost Study After CAR-T Therapy
Official title: Prospective Study of Autologous Hematopoietic Stem Cell Boost to Improve Myelosuppression in B-NHL Patients with High-risk Immunologic Hematologic Toxic After Chimeric Antigen Receptor T-Cell Immunotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 1-year overall survival
timeFrame: 1 year after CAR-T cell infusion
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: End of treatment visit (1 years after stem cell infusion)
measure: Best objective response rate
timeFrame: End of treatment visit (1 years after stem cell infusion)
measure: Best complete response rate
timeFrame: End of treatment visit (1 years after stem cell infusion)
measure: Time to reponse
timeFrame: End of treatment visit (1 years after stem cell infusion)
measure: Duration of response
timeFrame: End of treatment visit (1 years after stem cell infusion)
measure: Progression-free survival
timeFrame: End of treatment visit (1 years after stem cell infusion)
measure: Overall survival
timeFrame: End of treatment visit (1 years after stem cell infusion)
measure: Overall days of hospitalization
timeFrame: End of treatment visit (1 years after stem cell infusion)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References: