Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Ce... | NCT03110640

Studies
Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

NCT03110640

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Status

Unknown status

Last Update Posted

Nov 27, 2019Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

B-cell Adult Acute Lymphoblastic Leukemia
B-cell Chronic Lymphocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Hematopoietic/Lymphoid Cancer
Refractory Chronic Lymphocytic Leukemia

Interventions

anti-CD19 CAR-T
Fludarabine
Cyclophosphamide

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

Status Module

Record Verification Date

Nov 2019

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

Oct 1, 2016Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Sep 2021Estimated

First Submitted Date

Apr 6, 2017

First Submission Date that Met QC Criteria

Apr 11, 2017

First Posted Date

Apr 12, 2017Actual

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

Nov 25, 2019

Last Update Posted Date

Nov 27, 2019Actual

Name	Class
Hrain Biotechnology Co., Ltd.	INDUSTRY
Second Affiliated Hospital of Nanchang University	OTHER

Description Module

Brief Summary

This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

Detailed Description

Primary objectives

To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives
To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD9CAR-T transfer	Experimental	All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T	Biological: anti-CD19 CAR-T Drug: Fludarabine Drug: Cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti-CD19 CAR-T	Biological	Ex vivo-expanded autologous T cells modified to express CD19 CAR	CD9CAR-T transfer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety - incidence of adverse events defined as dose-limited toxicity	incidence of adverse events defined as dose-limited toxicity	180 days

Secondary Outcomes

Measure	Description	Time Frame
Overall complete remission rate	Overall complete remission rate	1 year
Duration of remission	Duration of remission	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

5 Years to 70 Years, Male and female;
Expected survival > 12 weeks;
Performance score 0-2;
Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
Creatinine < 2.5 mg/dl;
ALT/AST < 3x normal;
Bilirubin < 2.0 mg/dl;
Adequate venous access for apheresis, and no other contraindications for leukapheresis;
Take contraceptive measures before recruit to this trial;
Written voluntary informed consent is given.

Exclusion Criteria:

Patients with symptoms of central nervous system
Accompanied by other malignant tumor
Active hepatitis B or C, HIV infection
Any other diseases could affect the outcome of this trial
Suffering severe cardiovascular or respiratory disease
Poorly controlled hypertension
A history of mental illness and poorly controlled
Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
Reaching a steady dose if receiving anticoagulant therapy before assignment
Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
Pregnant or lactating women
Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Kang Yu, M.D.	Contact	55578037		yukang62@126.com

Name	Affiliation	Role
Kang Yu, M.D.	First Affiliated Hospital of Wenzhou Medical University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The First Affilicated Hospital of Wenzhou Medical University	Recruiting	Wenzhou	Zhejiang	325000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34935483	Derived	Dong R, Jiang S, Chen Y, Ma Y, Sun L, Xing C, Zhang S, Yu K. Prognostic Significance of Cytokine Release Syndrome in B Cell Hematological Malignancies Patients After Chimeric Antigen Receptor T Cell Therapy. J Interferon Cytokine Res. 2021 Dec;41(12):469-476. doi: 10.1089/jir.2021.0057.

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D019337	Hematologic Neoplasms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site

ID	Term
C024352	fludarabine
D003520	Cyclophosphamide

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds