Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma
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ClinicalTrials.gov Identifier: NCT02842138 |
Recruitment Status : Unknown
Verified February 2019 by Jun Zhu, Peking University.
Recruitment status was: Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : February 25, 2019
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Condition or disease | Intervention/treatment | Phase |
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B-cell Lymphoma | Biological: autologous anti-CD19 CAR T cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting CD19 in Patients With Relapsed or Refractory B-cell Lymphoma |
Study Start Date : | June 2016 |
Actual Primary Completion Date : | February 28, 2018 |
Estimated Study Completion Date : | August 2019 |
Arm | Intervention/treatment |
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Experimental: CD19 CAR T cells
A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.
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Biological: autologous anti-CD19 CAR T cells
Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%). |
- Number of patients with adverse events [ Time Frame: 2 years ]
- Treatment response rate of anti-CD19 CAR T cell infusion [ Time Frame: 4 weeks ]Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on standardized response criteria for malignant lymphoma (Cheson BD, JCO, 2007).
- overall survival rate of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]
- progression-free survival of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]
- Persistence of CAR T cells in patients [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- CD19+ B cell lymphoma,verified by IHC or flow cytometry.
- a prior history of at least two standard care of medication.
- ineligible for allogeneic transplantation or relapsed after transplantation.
- patients are 18 years older.
- life expectancy > 3months.
- ECOG ≤ 2.
- satisfactory major organ functions: adequate heart function with LVEF≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
- Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L.
- women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
- measurable tumors.
Exclusion Criteria:
- using immunosuppressive drugs or systemic steroids within one week of enrollment.
- active infection.
- HIV positive.
- active hepatitis B virus infection or hepatitis C virus infection.
- breastfeeding or pregnant women.
- patients refuse to practice birth control during study and one year post study.
- patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study.
- currently enrolled in other study.
- patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842138
China | |
Peking University Cancer Hospital | |
Beijing, China, 100142 |
Principal Investigator: | Jun Zhu, MD | Peking University Cancer Hospital & Institute |
Responsible Party: | Jun Zhu, Principal Investigator, Peking University |
ClinicalTrials.gov Identifier: | NCT02842138 |
Other Study ID Numbers: |
2016YJZ12 |
First Posted: | July 22, 2016 Key Record Dates |
Last Update Posted: | February 25, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |