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

• Sponsor: He Huang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05444322
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma; Follicular Lymphoma	Drug: RD14-01 cell infusion	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
• Actual Study Start Date: Jul 5, 2022
• Anticipated Primary Completion Date: Jul 10, 2024
• Anticipated Study Completion Date: Jul 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RD14-01 cell infusion Infused i.v. in a single dose	Drug: RD14-01 cell infusion; Autologous CAR T cells

Outcome Measures

Primary Outcome Measures

1. Dose-limiting toxicity [Up to 2 years]

   DLT

2. Maximum tolerable dose [Up to 2 years]

   MTD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

• He Huang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: He Huang, Clinical Professor, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05444322
• Other Study ID Numbers: BHCT-RD14-01
• First Posted: Jul 5, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Jul 11, 2022