Brief Summary

This is a single arm, open-label, phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T, an autologous tri-functional anti- CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in Refractory/ Relapsed CD19 Positive Non-Hodgkin Lymphoma (NHL).

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

October 24, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed

7 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed

Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

2.6 years

First QC Date

October 24, 2018

Last Update Submit

December 6, 2019

Conditions

Non-hodgkin Lymphoma,B Cell

Keywords

CAR-TTriCAR-TCD19-TriCAR-TNon-hodgkin LymphomaNHLCD19-CAR-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
24 months

Secondary Outcomes (5)

Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
24 months
Partial response rate [PR] （Partial response rate per the revised International Working Group (IWG) Response Criteria）
24 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)

CD19-TriCAR-T

EXPERIMENTAL

Tri-functional anti-CD19 chimeric antigen receptor transduced autologous T cells will be administered intravenously

Biological: CD19-TriCAR-T

Interventions

CD19-TriCAR-TBIOLOGICAL

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 0.1-1 x 10\^6 CAR+ T cells/kg body weight.

CD19-TriCAR-T

Eligibility Criteria

Age18 Years - 69 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;
Histologically or cytologically confirmed CD19 positive non-Hodgkin lymphoma;
At least one measurable lesion per revised IWG Response Criteria;
Aged 18 to 69 years;
Expected survival ≥12 weeks;
Eastern cooperative oncology group (ECOG) performance status of ≤2;
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 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;
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 think the patient may not be suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Timmune Biotech Inc.lead

Study Sites (1)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570100, China

RECRUITING

Related Publications (3)

Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. doi: 10.1016/j.ymthe.2016.10.020. Epub 2017 Jan 4.
PMID: 28129122BACKGROUND
Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19.
PMID: 28925994BACKGROUND
Kalos M, Levine BL, Porter DL, Katz S, Grupp SA, Bagg A, June CH. T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci Transl Med. 2011 Aug 10;3(95):95ra73. doi: 10.1126/scitranslmed.3002842.
PMID: 21832238BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Haifeng Lin
The Second Affiliated Hospital of Hainan Medical University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Haifeng Lin

CONTACT

+86 13322060949 13322060949@163.com

Bin Gao, Dr.

CONTACT

+86 022 59060560 bin.gao@timmune.com

Study Design

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

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Study Start

November 1, 2018

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

December 9, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

CD19-TriCAR-T

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations