CAR-T therapy for treating relapsed refractory blood cancers

Clinical Study of CAR-T Technology for the Treatment of Relapsed Refractory Malignant Haematological Tumours

This study is testing if CAR-T cell therapy can help people with tough-to-treat blood cancers that have come back after other treatments.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 14 Years to 70 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Drugs / interventions: CAR-T, cyclophosphamide, fludarabine
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT06238336 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CAR-T cell therapy in patients with relapsed refractory malignant hematological tumors. It involves a single-center, open-label design with a series of visits including screening, non-myeloablative preconditioning, and follow-up assessments over six months. Patients will receive CAR-T cell infusions after a preconditioning regimen and will be monitored for their response and any adverse effects. The study aims to provide insights into the potential benefits of CAR-T therapy for this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14 to 70 with relapsed refractory malignant hematological tumors who meet specific health criteria.

Not a fit: Patients who are pregnant, breastfeeding, or planning to conceive within the year may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Other studies have shown promising results with CAR-T therapy in similar patient populations, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. patients or their legal guardians voluntarily participate and sign an informed consent form;
2. male or female patients aged 14 to 70 years (inclusive);
3. be diagnosed as malignant haematological tumour by pathological and histological examination;
4. have a measurable or evaluable lesion;
5. the patient has good function of major tissues and organs:

(1) Liver function: ALT/AST \<3 times upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L; (2) Renal function: creatinine \<220 μmol/L; (3) Lung function: room oxygen saturation ≥95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. (6) Patient's peripheral superficial venous blood flow is smooth and can meet the demand of intravenous drip; 7. patients with ECOG score ≤2 and expected survival time ≥3 months.

Exclusion Criteria:

1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding;
2. men or women who are planning to conceive within the last 1 year;
3. patients who cannot guarantee effective contraception (condoms or birth control pills, etc.) within 1 year of enrolment;
4. patients with uncontrolled infections within 4 weeks prior to enrolment;
5. active viral hepatitis B/C;
6. patients with HIV infection;
7. patients with severe autoimmune diseases or immunodeficiency diseases;
8. patients who are allergic to large molecule biopharmaceuticals such as antibodies or cytokines;
9. patients who have participated in other clinical trials within 6 weeks prior to enrolment;
10. the patient has used hormones systematically within 4 weeks prior to enrolment (except for patients using inhaled hormones);
11. the patient has a psychiatric disorder
12. the patient has substance abuse/addiction;
13. other conditions that, in the judgement of the investigator, make the patient unsuitable for enrolment.

Where this trial is running

Taiyuan, Shanxi

• ShanxiBethuneH — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Xiaomin Zhang — Shanxi Bethune Hospital
• Study coordinator: Liangming Ma

Conditions Hematological Malignancy