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Treatment of Hematological Malignancy With Novel CAR-T Cells.

Primary Purpose

B-cell Non Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia, Multiple Myeloma

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Novel CAR-T

About this trial

This is an interventional treatment trial for B-cell Non Hodgkin Lymphoma focused on measuring CD19-TriCAR-T, 1922-TriCAR-T, BCMA-TriCAR-T

Eligibility Criteria

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

Inclusion Criteria:

All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
All subjects must be able to comply with all the scheduled procedures in the study;
Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
At least one clear indicator for hematological malignancy monitoring;
Aged <70 years;
Expected survival ≥12 weeks;
Eastern cooperative oncology group (ECOG) performance status of≤3;
Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
All other treatment induced adverse events must have been resolved to
≤grade 1;
Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion Criteria:

Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);
Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
Lactating women or women of childbearing age who plan to conceive during the investigational time period;
Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
Known history of infection with HIV;
Subjects need systematic usage of corticosteroid;
Subjects need systematic usage of immunosuppressive drug;
Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
Other reasons the investigator consider the patient may not be suitable for the study.

Sites / Locations

Hunan Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Novel CAR-T

Arm Description

Novel CAR-T cells will be administered intravenously

Outcomes

Primary Outcome Measures

safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)

Incidence of treatment-related adverse events as assessed by CTCAE v4.03

Secondary Outcome Measures

Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)

Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma

Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria)

Partial response rate per the revised International Working Group (IWG) Response Criteria

Duration of Response (The time from response to relapse or progression)

The time from response to relapse or progression

Progression Free Survival (The time from the first day of treatment to the date on which disease progresses)

The time from the first day of treatment to the date on which disease progresses

Overall Survival (The number of patient alive, with or without signs of cancer)

The number of patient alive, with or without signs of cancer

Full Information

NCT ID

NCT04191941

First Posted

December 6, 2019

Last Updated

December 6, 2019

Sponsor

Timmune Biotech Inc.

Collaborators

Hunan Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04191941

Brief Title

Treatment of Hematological Malignancy With Novel CAR-T Cells.

Official Title

Adoptive Immunotherapy for Hematological Malignancy With Novel CAR-T Cells.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Timmune Biotech Inc.

Collaborators

Hunan Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.

Detailed Description

The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment，as well as stimulating innate T/NK cell activation and expansion.

6. Conditions and Keywords

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

B-cell Non Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia, Multiple Myeloma

Keywords

CD19-TriCAR-T, 1922-TriCAR-T, BCMA-TriCAR-T

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Novel CAR-T Cell Therapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Novel CAR-T

Arm Type

Experimental

Arm Description

Novel CAR-T cells will be administered intravenously

Intervention Type

Biological

Intervention Name(s)

Novel CAR-T

Intervention Description

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of Novel CAR-T cells

Primary Outcome Measure Information:

Title

safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)

Description

Incidence of treatment-related adverse events as assessed by CTCAE v4.03

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)

Description

Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma

Time Frame

3 months

Title

Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria)

Description

Partial response rate per the revised International Working Group (IWG) Response Criteria

Time Frame

3 months

Title

Duration of Response (The time from response to relapse or progression)

Description

The time from response to relapse or progression

Time Frame

24 months

Title

Progression Free Survival (The time from the first day of treatment to the date on which disease progresses)

Description

The time from the first day of treatment to the date on which disease progresses

Time Frame

24 months

Title

Overall Survival (The number of patient alive, with or without signs of cancer)

Description

The number of patient alive, with or without signs of cancer

Time Frame

24 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All subjects must personally sign and date the consent form before initiating any study specific procedures or activities; All subjects must be able to comply with all the scheduled procedures in the study; Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma. Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT; At least one clear indicator for hematological malignancy monitoring; Aged <70 years; Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performance status of≤3; Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; All other treatment induced adverse events must have been resolved to ≤grade 1; Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome); Exclusion Criteria: Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator); Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator; Lactating women or women of childbearing age who plan to conceive during the investigational time period; Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive); Known history of infection with HIV; Subjects need systematic usage of corticosteroid; Subjects need systematic usage of immunosuppressive drug; Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study; Other reasons the investigator consider the patient may not be suitable for the study.

Central Contact Person:

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

Ming Zhou

Phone

+86 0731 83928147

zhouming_0321@163.com

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

Bin Gao

Phone

+86 022 59060560

Ext

803

bin.gao@timmune.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Zhou

Organizational Affiliation

Hunan Provincial People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hunan Provincial People's Hospital

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410005

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Zhou

Phone

+86 0731 83928147

zhouming_0321@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Hematological Malignancy With Novel CAR-T Cells.

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