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

Early Phase 1

Recruiting

• Conditions: Mantle Cell Lymphoma; Follicular Lymphoma; Diffuse Large B-cell Lymphoma
• Interventions: Drug: RD14-01 cell infusion

• Registration Number: NCT05444322
• Lead Sponsor: He Huang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Status Verified: 2022-07
• Study Start: 2022-07-05
• Study First Posted: 2022-07-05
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-11
• Primary Completion: 2024-07-10
• Study Completion: 2025-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RD14-01 cell infusion	RD14-01 cell infusion	Infused i.v. in a single dose

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	Up to 2 years	DLT
Maximum tolerable dose	Up to 2 years	MTD

Trial Locations

Locations (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China