Treatment of Hematological Malignancy With Novel CAR-T Cells.

NCT04191941 | Unknown Early Phase 1 DMC

• 1 other identifier: 2019-24.1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  3 months

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

  3 months

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

  24 months

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

  24 months

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

  24 months

Study Arms (1)

Novel CAR-T

EXPERIMENTAL

Novel CAR-T cells will be administered intravenously

Biological: Novel CAR-T

Interventions

Novel CAR-T BIOLOGICAL

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

Novel CAR-T

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Timmune Biotech Inc.: lead
• Hunan Provincial People's Hospital: collaborator

Study Sites (1)

Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Burkitt Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Ming Zhou

  Hunan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zhou

CONTACT

+86 0731 83928147; zhouming_0321@163.com

Bin Gao

CONTACT

+86 022 59060560; bin.gao@timmune.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Novel CAR-T Cell Therapy

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: September 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)