Treatment of Hematological Malignancy With Novel CAR-T Cells.

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191941
• Other study ID #: 2019-24.1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2019
• Source: Timmune Biotech Inc.
• Contact: Ming Zhou
• Phone: +86 0731 83928147
• Email: zhouming_0321[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• B-cell Non Hodgkin Lymphoma
• Burkitt Lymphoma
• Lymphoma, B-Cell
• Multiple Myeloma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Hunan Provincial People's Hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Timmune Biotech Inc.	Hunan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	Duration of Response (The time from response to relapse or progression)	The time from response to relapse or progression	24 months
Secondary	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	24 months
Secondary	Overall Survival (The number of patient alive, with or without signs of cancer)	The number of patient alive, with or without signs of cancer	24 months