Exploring RD14-01 for patients with relapsed B-cell non-Hodgkin lymphoma
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
This study is testing a new cell treatment called RD14-01 to see if it is safe and effective for people with relapsed B-cell non-Hodgkin lymphoma.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05444322 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and tolerability of RD14-01, a cell infusion treatment, in patients suffering from relapsed or refractory B-cell non-Hodgkin lymphoma, including mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. The study aims to evaluate the efficacy and pharmacokinetics of RD14-01 in this patient population. Participants will be closely monitored for any adverse effects and treatment responses throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, or follicular lymphoma.
Not a fit: Patients with active central nervous system metastases or those with certain viral infections such as HIV or hepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell non-Hodgkin lymphoma.
How similar studies have performed: While this approach is novel, similar studies targeting B-cell non-Hodgkin lymphoma have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 to 75 years. 2. Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a). 3. ECOG: 0-1. 4. Life expectancy greater than 3 months. 5. Cardiac left ventricle ejection fraction ≥50%. 6. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent. Exclusion Criteria: 1. Pregnant or lactating. 2. Hepatitis B surface antigen (HBsAg) or hepatitis B e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive. 3. Central nervous system (CNS) metastases. 4. Participated in other clinical studies within 4 weeks prior to screening. 5. History of alcoholism, drug abuse or mental illness. 6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: He Huang, PhD
- Email: hehuangyu@126.com
- Phone: 86-13605714822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.