Treatment of Hematological Malignancy With Novel CAR-T Cells.

Sponsor

Timmune Biotech Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04191941

Collaborator

Hunan Provincial People's Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
B-cell Non Hodgkin Lymphoma B-cell Acute Lymphoblastic Leukemia Multiple Myeloma	Biological: Novel CAR-T	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Novel CAR-T Cell TherapyNovel CAR-T Cell Therapy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Novel CAR-T Novel CAR-T cells will be administered intravenously	Biological: Novel CAR-T A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of Novel CAR-T cells

Arm

Intervention/Treatment

Experimental: Novel CAR-T

Novel CAR-T cells will be administered intravenously

Biological: Novel CAR-T

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

Outcome Measures

Primary Outcome Measures

safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) [3 months]
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) [3 months]
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) [3 months]
Partial response rate per the revised International Working Group (IWG) Response Criteria
Duration of Response (The time from response to relapse or progression) [24 months]
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) [24 months]
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) [24 months]
The number of patient alive, with or without signs of cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 70 Years

Sexes Eligible for Study:

All

Accepts 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.