Boosting stem cells after CAR-T therapy for lymphoma patients

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

This study tests whether giving stem cells to lymphoma patients who have had CAR-T therapy can help them recover from low blood cell counts and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: CAR-T, immunotherapy, CART, Chimeric Antigen Receptor
• Locations: 1 site (Shanghai)
• Trial ID: NCT06589089 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of using autologous hematopoietic stem cells to improve bone marrow suppression in patients with diffuse large B cell lymphoma who have undergone CAR-T therapy. It is a prospective, single-arm, open-label study where patients experiencing unrelieved hematologic toxicity after CAR-T therapy may receive a stem cell infusion. If myelosuppression persists, additional stem cell infusions may be administered. The goal is to enhance recovery from hematologic toxicity following immunotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of B-cell non-Hodgkin lymphoma who have undergone CAR-T therapy and are at high risk for hematologic toxicity.

Not a fit: Patients who do not have myelosuppression after CAR-T therapy or those without a reserve of stem cells may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery from hematologic toxicity in lymphoma patients after CAR-T therapy.

How similar studies have performed: While the specific approach of using stem cell boosts after CAR-T therapy is novel, similar strategies in managing hematologic toxicity have shown promise in other studies.

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.

Where this trial is running

Shanghai

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Weili Zhao, Doctor

Conditions: Diffuse Large B Cell Lymphoma