Safety and Efficacy Evaluation of IM19 Cells

NCT03344705 | Unknown Phase 1

• 1 other identifier: YMCART201701
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• Occurrence of study related adverse events

  defined as \>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

  2 years

Secondary Outcomes (1)

• Overall response rate

  2 years

Study Arms (1)

IM19 CART

EXPERIMENTAL

All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.

Biological: IM19 CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

IM19 CAR-T BIOLOGICAL

All patients will be treated with fludarabine and cyclophosphamide for 3 days. Two days later, Cells Expressing an Anti-CD19 Chimeric Antigen Receptor will be infused.

Also known as: IM19

IM19 CART

Fludarabine DRUG

Two days before cell infusion,all patients will be treated with fludarabine for 3 days

Also known as: F

IM19 CART

Cyclophosphamide DRUG

Two days before cell infusion,all patients will be treated with cyclophosphamide for 3 days

Also known as: C

IM19 CART

Eligibility Criteria

• Age: 4 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CD19 positive relapsed or refractory B-cell malignancies, including B-cell Acute Lymphocytic Leukemia(ALL)、B-cell Chronic Lymphocytic Leukemia(CLL)、Non-Hodgkin's lymphoma(NHL).
• )Patients with ALL:
• Previously treated with at least two courses of chemotherapy Ⅱ The interval of the last chemotherapy and disease progression is less than one year.
• Ⅲ Not suitable for allogeneic stem cell transplantation. 2)Patients with CLL:
• Previously treated with at least two courses of chemotherapy
• Ⅱ The interval of the last chemotherapy and disease progression is less than two years.
• Ⅲ Not suitable for allogeneic stem cell transplantation conditions or due to conditions to abandon allogeneic stem cell transplantation.
• \) Patients with DLBCL or FL、PMBCL:
• Patients who relapsed or were refractory after at least two previous treatments.
• Ⅱ Patients who relapsed after transplantation. 4)Patients who have relapsed or have refractory mantle cell lymphoma after at least one treatment.
• Measurable disease,including minimal residual disease. 3.Gender is not limited, to be aged 4 to 75 years 4.Expected survival \>3 months. 5.Eastern Cooperative Oncology Group(ECOG) score 0-2. 6.Women of childbearing potential must have a blood pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
• Absence of symptoms of central nervous system(CNS) leukemia.

You may not qualify if:

• Patients who have been treated with chemotherapy or radiotherapy within 2 weeks before blood collection.
• Patients have GVHD, which needs treatment with immunosuppressive agents,or patients with autoimmune diseases.
• Patient who have been treated with systemic steroid medication within two weeks of blood collection（Except for the recent or current use of inhaled steroids）.
• Patient who have been treated with stimulation of bone marrow hematopoietic cells generated drugs(Such as Recombinant Human Granulocyte Colony-stimulating Factor Injection) within 2 weeks before the blood collection period to use .
• The number of T cells in peripheral blood is lower than 2×10\^8/L.
• Previously treatment with any gene therapy products.
• History of epilepsy or other CNS disease.
• New York Heart Association(NYHA) grade≥Ⅲ.
• Creatinine\> 1.5×normal value，Alanine transaminase(ALT) /Aspartate aminotransferase(AST)\>3×normal value，Bilirubin \>2×normal value.
• Degree of myeloproliferation： Ⅳ-V
• Active hepatitis B , hepatitis C or HIV infection and cytomegalovirus infection ,Epstein-Barr virus infection or any other uncontrolled active infection.
• Pregnancy or breast-feeding women.
• Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
• Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

• Bao F, Wan W, He T, Qi F, Liu G, Hu K, Lu XA, Yang P, Dong F, Wang J, Jing H. Autologous CD19-directed chimeric antigen receptor-T cell is an effective and safe treatment to refractory or relapsed diffuse large B-cell lymphoma. Cancer Gene Ther. 2019 Jul;26(7-8):248-255. doi: 10.1038/s41417-018-0073-7. Epub 2019 Jan 9.

  PMID: 30622321 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Hongmei Jing, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin-an Lu, Dr

CONTACT

86-189-1157-6946; luxinan@immunochina.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: November 14, 2017
• First Posted: November 17, 2017
• Study Start: August 21, 2017
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

CN (1)