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Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B cell hematologic malignancies including acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma (NHL), multiple myeloma

A Single center Efficacy and Safety Study of Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL), multiple myeloma

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17013135
Enrollment
Unknown
Registered
2017-10-28
Start date
2016-09-17
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory/Relapsed hematologic malignancies

Interventions

1:CART cell infusion

Sponsors

The third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 6 to 65 years old (Multiple Myeloma patients aged 6 to 75 years old); 2. Patients should understand and are willing to participate in the trial. Inform consent form is supposed to obtained before treatment; 3. Expected survival> 3 months; 4. Indications: (1) Patients diagnosed as CD19/CD20/CD22/CD33/CD123/CLL-1/CD138/BCMA/CD30 positive B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma Measurable disease; (2) unsuitable, unconditional or patient unwilling to carry out hematopoietic stem cell transplantation; or have no suitable donor; (3) Refractory/Relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma; (4) Relapse after stem cell transplantation. 5. Organ function: (1) Cardiac function: Left Ventricular Ejection Fraction (LVEF) > 40% (echocardiography) in the latest month; (2) liver function: alanine aminotransferase and aspartate aminotransferase 92%. 6. Karnofsky score> 60; 7. Eastern Cooperative Oncology Group(ECOG) Performance status 3 months; 4. Indications: (1) Patients diagnosed as CD19/CD20/CD22/CD33/CD123/CLL-1/CD138/BCMA/CD30 positive B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma Measurable disease; (2) unsuitable, unconditional or patient unwilling to carry out hematopoietic stem cell transplantation; or have no suitable donor; (3) Refractory/Relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma; (4) Relapse after stem cell transplantation. 5. Organ function: (1) Cardiac function: Left Ventricular Ejection Fraction (LVEF) > 40% (echocardiography) in the latest month; (2) liver function: alanine aminotransferase and aspartate aminotransferase 92%. 6. Karnofsky score> 60; 7. Eastern Cooperative Oncology Group(ECOG) Performance status 3 months; 4. Indications: (1) Patients diagnosed as CD19/CD20/CD22/CD33/CD123/CLL-1/CD138/BCMA/CD30 positive B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma Measurable disease; (2) unsuitable, unconditional or patient unwilling to carry out hematopoietic stem cell transplantation; or have no suitable donor; (3) Refractory/Relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma; (4) Relapse after stem cell transplantation. 5. Organ function: (1) Cardiac function: Left Ventricular Ejection Fraction (LVEF) > 40% (echocardiography) in the latest month; (2) liver function: alanine aminotransferase and aspartate aminotransferase 92%. 6. Karnofsky score> 60; 7. Eastern Cooperative Oncology Group(ECOG) Performance status 3 months; 4. Indications: (1) Patients diagnosed as CD19/CD20/CD22/CD33/CD123/CLL-1/CD138/BCMA/CD30 positive B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma Measurable disease; (2) unsuitable, unconditional or patient unwilling to carry out hematopoietic stem cell transplantation; or have no suitable donor; (3) Refractory/Relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma; (4) Relapse after stem cell transplantation. 5. Organ function: (1) Cardiac function: Left Ventricular Ejection Fraction (LVEF) > 40% (echocardiography) in the latest month; (2) liver function: alanine aminotransferase and aspartate aminotransferase 92%. 6. Karnofsky score> 60; 7. Eastern Cooperative Oncology Group(ECOG) Performance status 3 months; 4. Indications: (1) Patients diagnosed as CD19/CD20/CD22/CD33/CD123/CLL-1/CD138/BCMA/CD30 positive B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma Measurable disease; (2) unsuitable, unconditional or patient unwilling to carry out hematopoietic stem cell transplantation; or have no suitable donor; (3) Refractory/Relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma(NHL)multiple myeloma; (4) Relapse after stem cell transplantation. 5. Organ function: (1) Cardiac function: Left Ventricular Ejection Fraction (LVEF) > 40% (echocardiography) in the latest month; (2) liver function: alanine aminotransferase and aspartate aminotransferase 92%. 6. Karnofsky score> 60; 7. Eastern Cooperative Oncology Group(ECOG) Performance status <2; 8. Medication situation: (1) did not receive systemic chemotherapy within 1 month; (2) no other immunotherapy within 3 month.

Exclusion criteria

Exclusion criteria: 1. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection); 2. Known human immunodeficiency virus (HIV) infection; 3. Myocardial infarction, severe arrhythmia history within 6 months; 4. Congenital immuno-deficient patients; 5. Patient and / or the family members disagree with the treatment plan; 6. Pregnancy.;Exclusion criteria: 1. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection); 2. Known human immunodeficiency virus (HIV) infection; 3. Myocardial infarction, severe arrhythmia history within 6 months; 4. Congenital immuno-deficient patients; 5. Patient and / or the family members disagree with the treatment plan; 6. Pregnancy.;Exclusion criteria: 1. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection); 2. Known human immunodeficiency virus (HIV) infection; 3. Myocardial infarction, severe arrhythmia history within 6 months; 4. Congenital immuno-deficient patients; 5. Patient and / or the family members disagree with the treatment plan; 6. Pregnancy.;Exclusion criteria: 1. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection); 2. Known human immunodeficiency virus (HIV) infection; 3. Myocardial infarction, severe arrhythmia history within 6 months; 4. Congenital immuno-deficient patients; 5. Patient and / or the family members disagree with the treatment plan; 6. Pregnancy.;Exclusion criteria: 1. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection); 2. Known human immunodeficiency virus (HIV) infection; 3. Myocardial infarction, severe arrhythmia history within 6 months; 4. Congenital immuno-deficient patients; 5. Patient and / or the family members disagree with the treatment plan; 6. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Tumor load;

Secondary

MeasureTime frame
CAR T cell persistence;

Countries

China

Contacts

Public ContactLi Xin;Li Xin;Li Xin;Li Xin;Li Xin ;;;;

The third Xiangya Hospital of Central South University;The third Xiangya Hospital of Central South University;The third Xiangya Hospital of Central South University;The third Xiangya Hospital of Central South University;The third Xiangya Hospital of Central South University

972978226@qq.com;972978226@qq.com;972978226@qq.com;972978226@qq.com;972978226@qq.com+86 0731-88618241;+86 0731-88618241;+86 0731-88618241;+86 0731-88618241;+86 0731-88618241

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026