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Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL

Primary Purpose

Leukemia, Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Anti-CD19-CAR γδT

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Lymphoma, CAR γδT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
KPS>60.
Life expectancy>3 months.
Gender unlimited, age from 18 years to 70 years.
CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
Patients who have failed at least one line of a standard treatment.
No serious mental disorder.
Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
No other serious diseases(autoimmune disease, immunodeficiency etc.).
No other tumors.
Patients volunteer to participate in the research.
Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to infusion.

Exclusion Criteria:

KPS<50.
Patients are allergic to cytokines.
Central nervous system leukemia within 28 days.
Uncontrolled active infection.
Acute or chronic GVHD.
Treated with T cell inhibitor.
Pregnancy and nursing females.
HIV/HBV/HCV Infection.
Other situations we think improper for the research.

Sites / Locations

Beijing DOING Biomedical Co., Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Experimental: 1

Experimental: 2

Experimental: 3

Arm Description

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Chronic lymphoblastic leukemia with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Non-hodgkin lymphoma treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Outcomes

Primary Outcome Measures

Adverse events of each patient.

Adverse events of each patient will be recorded and analysed.

Secondary Outcome Measures

Survival time of Anti-CD19 CAR γδT cells in vivo.

PCR will be applied to analyse the survival time of Anti-CD19 CAR γδT cells in vivo.

Antitumor Effects

Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.

Full Information

NCT ID

NCT02656147

First Posted

January 12, 2016

Last Updated

September 1, 2017

Sponsor

Beijing Doing Biomedical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02656147

Brief Title

Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL

Official Title

Phase I Study of γδT Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2017 (Anticipated)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Doing Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed CD19+ haematological malignancies.

Detailed Description

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) γδT-cells (CD19 CAR γδT-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR γδT-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR γδT-cells in patients with high risk relapsed CD19+ malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphoma

Keywords

Leukemia, Lymphoma, CAR γδT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: 1

Arm Type

Experimental

Arm Description

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Arm Title

Experimental: 2

Arm Type

Experimental

Arm Description

Chronic lymphoblastic leukemia with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Arm Title

Experimental: 3

Arm Type

Experimental

Arm Description

Non-hodgkin lymphoma treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.

Intervention Type

Biological

Intervention Name(s)

Anti-CD19-CAR γδT

Intervention Description

Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)

Primary Outcome Measure Information:

Title

Adverse events of each patient.

Description

Adverse events of each patient will be recorded and analysed.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Survival time of Anti-CD19 CAR γδT cells in vivo.

Description

PCR will be applied to analyse the survival time of Anti-CD19 CAR γδT cells in vivo.

Time Frame

3 years

Title

Antitumor Effects

Description

Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Time Frame

Every 3 months post treatment up to 24 months

Title

Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.

Description

Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma. KPS>60. Life expectancy>3 months. Gender unlimited, age from 18 years to 70 years. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. Patients who have failed at least one line of a standard treatment. No serious mental disorder. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L). No other serious diseases(autoimmune disease, immunodeficiency etc.). No other tumors. Patients volunteer to participate in the research. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to infusion. Exclusion Criteria: KPS<50. Patients are allergic to cytokines. Central nervous system leukemia within 28 days. Uncontrolled active infection. Acute or chronic GVHD. Treated with T cell inhibitor. Pregnancy and nursing females. HIV/HBV/HCV Infection. Other situations we think improper for the research.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xie yanyun, master

Phone

+8615601041145

yanyun_xie@doingtimes.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li gangyi, master

Phone

+8613601204100

gangyi_li@doingtimes.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li gangyi, master

Organizational Affiliation

Beijing Doing Biomedical Co., Ltd.

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing DOING Biomedical Co., Ltd

City

Beijing

ZIP/Postal Code

100021

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL

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