Treatment of Hematological Malignancy With Novel CAR-T Cells.

Early Phase 1

• Conditions: B-cell Non Hodgkin Lymphoma; B-cell Acute Lymphoblastic Leukemia; Multiple Myeloma
• Interventions: Biological: Novel CAR-T

• Registration Number: NCT04191941
• Lead Sponsor: Timmune Biotech Inc.

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.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Last Update Submitted: 2019-12-06
• Study First Posted: 2019-12-10
• Last Update Posted: 2019-12-10
• Primary Completion: 2021-08-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel CAR-T	Novel CAR-T	Novel CAR-T cells will be administered intravenously

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Duration of Response (The time from response to relapse or progression)	24 months	The time from response to relapse or progression
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
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
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

Trial Locations

Locations (1)

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China