Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia

NCT04289220 | Unknown Phase 1 DMC

• 1 other identifier: 2019-1-N-25318000002027
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Our previous study demonstrated that anti-CD19 chimeric antigen receptor in piggyBac transposon-engineered T cells have strong tumor-killing activity in vitro and therapeutic effects in cell line-derived xenograft models, and no obvious side effects such as neurotoxicity and cytokine storm occurred. Therefore, we want to evaluate the safety and clinical effect of anti-CD19 CAR-T cells in clinical trials.

Conditions

B Cell Lymphoma; B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Grade and number of cytokine release syndrome and neurotoxic effects in participants receiving treatment

  Anti-CD19 CAR-T cells growing use requires further education/training and prompt management of safety and tolerability.

  14 day

• Persistence of anti-CD19 CAR-T cells in participants

  Copies numbers of CAR in peripheral blood (PB)

  1 year

Secondary Outcomes (3)

• Overall survival

  3 years

• Progress Free Survival

  3 years

• Duration of Response after administration

  3 years

Study Arms (1)

Anti-CD19 CAR-T Cells Injection

EXPERIMENTAL

Anti-CD19 CAR-T Cells Injection, Dosage form：injection Dosage:1-2.5x10\^6/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time

Biological: Anti-CD19 CAR-T Cells Injection

Interventions

Anti-CD19 CAR-T Cells Injection BIOLOGICAL

Dosage form：injection Dosage:1-2.5x10\^6 cells/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time

Anti-CD19 CAR-T Cells Injection

Eligibility Criteria

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

You may qualify if:

• Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;
• Male or female patients aged 18 to 70 years (inclusive);
• Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program;
• B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:1) B-cell acute lymphoblastic leukemia;2) Indolent B-cell lymphomas;3) Aggressive B-cell lymphoma; 4) Multiple myeloma;
• Subjects:
• (1) Residual lesions remain after treatment and Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (2) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (3) Patients with high risk factors; (4) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.
• \. Have measurable or evaluable tumor foci;
• \. Liver, kidney and cardiopulmonary functions meet the following requirements:
• \) Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) \<3 ×upper limit of normal (ULN);2) Total bilirubin ≤34.2μmol/L;3) Serum creatinine\<220μmol/L;4) Baseline oxygen saturation≥95%;5) Left ventricular ejection fraction（LVEF）≥40%.
• \. Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss);
• \. Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip;
• \. Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2,Expected survival≥3 months;

You may not qualify if:

• Pregnant (urine/blood pregnancy test positive) or lactating women;
• Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
• Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment;
• Active or uncontrollable infection within four weeks prior to enrollment;
• Patients with active hepatitis B/C;
• HIV-infected patients;
• Severe autoimmune or immunodeficiency disorders;
• Patients are allergic to macromolecule drugs such as antigens or cytokines;
• Subjects participated in other clinical trials within 6 weeks before enrollment;
• Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
• Mental illness;
• Drug abuse/addiction;
• The investigators consider other conditions unsuitable for enrollment.

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Kunming Yan'an Hospital

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Burkitt Lymphoma

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

Study Officials

• Zongliu Hou

  Kunming Yan'an Hospital

  STUDY DIRECTOR

Central Study Contacts

Zongliu Hou

CONTACT

86-0871-63211157; hzl579@163.com

Study Design

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

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: March 15, 2020
• Primary Completion: March 15, 2023
• Study Completion: September 15, 2023
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

CN (1)