Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia

NCT02735291 | Unknown DMC

• 1 other identifier: 2015-06-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.

Conditions

Leukemia

Keywords

Leukemia CAR-T

Outcome Measures

Primary Outcomes (1)

• The overall efficiency

  The number of complete remission (CR) +The number of complete remission with incomplete hematologic recovery (CRi)/Total number of cases being treated

  5 years

Study Arms (1)

Single arm

EXPERIMENTAL

Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times

Biological: CD19-targeted CAR-T cells

Interventions

CD19-targeted CAR-T cells BIOLOGICAL

This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..

Single arm

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with acute non T lymphocytic leukemia after conventional treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirm the leukemia cells express can intervene molecular targets;
• Age 3 to 75 years old, both male and female;
• Is expected to survive more than 3 months;
• Physical condition is good: 0-2 score ECOG score;
• General requirements peripheral blood as basic normal (i.e., white blood cells \>= 4.0 x10\^9 / L, hemoglobin \> 100 g/L, the platelet count\>= 50 x10\^9 / L ), progress faster, in patients with special severe fully inform the patient related risk and gain understanding and consent, peripheral blood cell index can be extended to white blood cells \>= 2.0 x10\^9 / L, hemoglobin \> 60 g/L, the platelet count \>= 30 x10\^9 / L. But blood T lymphocytes in peripheral blood count must \>=0.2 x10\^9 / L;
• No obvious abnormal heart, liver and kidney function (namely basic normal ecg; kidney function: Cr \<=2.0 x ULN (Upper limit of normal value ); liver function: Alt/aspartate aminotransferase acuities \<=2.5 x ULN, BIL\<= 2.0 x ULN) , no large wounds that haven't healed on the body;
• Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

You may not qualify if:

• Various types of T lymphocyte leukemia, etc;
• Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
• Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more.
• Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
• Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution.
• Coagulation abnormalities and severe thrombosis;
• Pregnancy and lactation women;
• Any other chronic disease patients who have been treated with immune agents or hormone therapy;
• Patients who have participated in other clinical trials or other clinical trials in the past 30 days
• The Investigator believe the patients should not participate in this experiment.

Sponsors & Collaborators

• Sinobioway Cell Therapy Co., Ltd.: lead
• The Second Hospital of Anhui Medical University: collaborator

Study Sites (2)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

No. 454 Hospital of People'S Liberation Army

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• An F, Wang H, Liu Z, Wu F, Zhang J, Tao Q, Li Y, Shen Y, Ruan Y, Zhang Q, Pan Y, Zhu W, Qin H, Wang Y, Fu Y, Feng Z, Zhai Z. Influence of patient characteristics on chimeric antigen receptor T cell therapy in B-cell acute lymphoblastic leukemia. Nat Commun. 2020 Nov 23;11(1):5928. doi: 10.1038/s41467-020-19774-x.

  PMID: 33230103 DERIVED

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zhimin Zhai, Professor

  Chief physician

  PRINCIPAL INVESTIGATOR

• Hui Liao, Doctor

  Chief physician

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 12, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2025
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)