A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Trial end date: 2025-07-10
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: He Huang

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.