Treatment of Hematological Malignancy With Novel CAR-T Cells.

NCT ID: NCT04191941

Last Updated: 2019-12-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-12-31

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.

Conditions

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

Keywords

CD19-TriCAR-T; 1922-TriCAR-T; BCMA-TriCAR-T

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Novel CAR-T

Novel CAR-T cells will be administered intravenously

Group Type: EXPERIMENTAL

Novel CAR-T

Intervention Type: BIOLOGICAL

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

Interventions

Novel CAR-T

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;

2. All subjects must be able to comply with all the scheduled procedures in the study;

3. Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.

4. Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;

5. At least one clear indicator for hematological malignancy monitoring;

6. Aged <70 years;

7. Expected survival ≥12 weeks;

8. Eastern cooperative oncology group (ECOG) performance status of≤3;

9. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;

10. All other treatment induced adverse events must have been resolved to

≤grade 1;

11. 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

1. Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);

2. 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;

3. Lactating women or women of childbearing age who plan to conceive during the investigational time period;

4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);

5. Known history of infection with HIV;

6. Subjects need systematic usage of corticosteroid;

7. Subjects need systematic usage of immunosuppressive drug;

8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;

9. Other reasons the investigator consider the patient may not be suitable for the study.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Timmune Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Zhou

Role: PRINCIPAL_INVESTIGATOR

Hunan Provincial People's Hospital

Locations

Hunan Provincial People's Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Zhou

Role: CONTACT

Phone: +86 0731 83928147

Email: zhouming_0321@163.com

Bin Gao

Role: CONTACT

Phone: +86 022 59060560

Email: bin.gao@timmune.com

Facility Contacts

Ming Zhou

Role: primary

Other Identifiers

2019-24.1

Identifier Type: -

Identifier Source: org_study_id