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

NCT ID: NCT05444322

Last Updated: 2022-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2025-07-10

Brief Summary

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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

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Conditions

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Mantle Cell Lymphoma Diffuse Large B-cell Lymphoma Follicular Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RD14-01 cell infusion

Infused i.v. in a single dose

Group Type EXPERIMENTAL

RD14-01 cell infusion

Intervention Type DRUG

Autologous CAR T cells

Interventions

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RD14-01 cell infusion

Autologous CAR T cells

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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He Huang

OTHER

Sponsor Role lead

Responsible Party

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He Huang

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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He Huang, PhD

Role: CONTACT

86-13605714822

Facility Contacts

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He Huang, PhD

Role: primary

86-13605714822

Other Identifiers

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BHCT-RD14-01

Identifier Type: -

Identifier Source: org_study_id

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