A Study of RD14-01 in Patients With Relapsed or Refractor... | NCT05444322

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

NCT05444322

Sponsor

He Huang

Status

Unknown status

Last Update Posted

Jul 11, 2022Actual

Enrollment

18Estimated

Phase

Early Phase 1

Conditions

Mantle Cell Lymphoma
Diffuse Large B-cell Lymphoma
Follicular Lymphoma

Interventions

RD14-01 cell infusion

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2022Actual

Primary Completion Date

Jul 10, 2024Estimated

Completion Date

Jul 10, 2025Estimated

First Submitted Date

Jun 29, 2022

First Submission Date that Met QC Criteria

Jun 29, 2022

First Posted Date

Jul 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2022

Last Update Posted Date

Jul 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RD14-01 cell infusion	Experimental	Infused i.v. in a single dose	Drug: RD14-01 cell infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RD14-01 cell infusion	Drug	Autologous CAR T cells	RD14-01 cell infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose-limiting toxicity	DLT	Up to 2 years
Maximum tolerable dose	MTD	Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 to 75 years.
Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
ECOG: 0-1.
Life expectancy greater than 3 months.
Cardiac left ventricle ejection fraction ≥50%.
Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.

Exclusion Criteria:

Pregnant or lactating.
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.
Central nervous system (CNS) metastases.
Participated in other clinical studies within 4 weeks prior to screening.
History of alcoholism, drug abuse or mental illness.
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
He Huang, PhD	Contact	86-13605714822		hehuangyu@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital, College of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310003	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020522	Lymphoma, Mantle-Cell
D016403	Lymphoma, Large B-Cell, Diffuse
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided