Treatment of Children CD19+ Leukemia and Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy

NCT03910842 | Unknown Early Phase 1 DMC

• 1 other identifier: T2018-14
• Study Type: interventional
• Target: 12
• 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 CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Children CD19+ Leukemia Non-Hodgkin lymphoma treatment.

Conditions

Non-Hodgkin Lymphoma of Intestine; Leukemia

Keywords

Non-Hodgkin Lymphoma; Leukemia; children; CD19; CAR-T; TriCAR-T; TriCAR-SILK

Outcome Measures

Primary Outcomes (1)

• safty (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)

  Incidence of treatment-related adverse events as assessed by CTCAE v4.03

  24 monthes

Secondary Outcomes (1)

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

  24 monthes

Other Outcomes (4)

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

  24 monthes

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

  24 monthes

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

  24 monthes

Study Arms (1)

CD19-TriCAR-T/NK（SILK）

EXPERIMENTAL

CD19-TriCAR-T/SILK cells will be administered intravenously

Biological: CD19-TriCAR-T/SILK

Interventions

CD19-TriCAR-T/SILK BIOLOGICAL

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.

CD19-TriCAR-T/NK（SILK）

Eligibility Criteria

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

You may qualify if:

• For children CD19 positive B cell leukemia：
• All subjects must personally sign and date the Informed Consent before initiating any study specific procedures or activities;
• All subjects must be able to comply with all the scheduled procedures in the study;
• CD19-positive B-cell leukemia with histology or cytology confirmed recurrence after treatment; or progression during treatment; or after first line treatment getting a MRD negative, 2 times of MRD show\>0.01% but without bone marrow morphology recurrence;
• At least one measurable lesion;
• Aged \<18 years; or diagnosised at the age of less than 18 and relapsed within three years， determined by the investigator;
• Expected survival ≥12 weeks;
• Eastern cooperative oncology group(ECOG) performance status of≤2;
• Before CD19-TriCAR-T/SILK cell infusion, 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;
• For children CD19 positive B cell lymphoma：
• All subjects must personally sign and date the Informed Consent before initiating any study specific procedures or activities;
• All subjects must be able to comply with all the scheduled procedures in the study;
• CD19-positive B-cell lymphoma with histology or cytology confirmed recurrence after treatment，defined as one or more of the following: disease progression during standard therapy；recurrence after termination of treatment；relapse after autologous hematopoietic stem cell transplantation；not suitable for stem cell transplantation or abandon stem cell transplantation due to conditional restrictions;
• At least one measurable lesion;

You may not qualify if:

• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring iv antimicrobials for management. (Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment);
• 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 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

Leukemia; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xiangling He

  Hunan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangling He

CONTACT

+86 13873102615; hexiangl@163.com

Keke Chen

CONTACT

+86 13974931408; chenkeke1982@126.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

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: March 21, 2019
• Primary Completion: April 15, 2022
• Study Completion: October 15, 2022
• Last Updated: September 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)