Condition or disease | Intervention/treatment | Phase |
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Relapsed or Refractory Hematological Malignancies | Biological: CNCT19 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Study of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory B Cell Malignancies |
Estimated Study Start Date : | July 2019 |
Estimated Primary Completion Date : | July 2020 |
Estimated Study Completion Date : | April 2022 |
Arm | Intervention/treatment |
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Experimental: A
Single dose of CNCT19
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Biological: CNCT19
0.5 to 4 x 10^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10^8 autologous CNCT19 transduced cells via intravenous infusion.
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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:
Relapsed or refractory B-cell lineage acute lymphoblastic leukemia (B-ALL)
Relapsed or refractory
Relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with CD19-positive after two systemic lines of therapy
Chemotherapy-refractory disease, defined as one of more of the following:
Refractory post-autologous stem cell transplant (ASCT) or allogeneic stem cell transplantation (allo-HSCT).
i. Disease progression or relapsed less than or equal to 12 months of ASCT /allo-HSCT (must have biopsy proven recurrence in relapsed individuals).
ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy Any BM relapse after autologous/allogeneic stem cell transplantation (SCT).
Individuals must have received two systemic lines of therapy
Relapsed or refractory chronic lymphocytic leukemia (CLL) with CD19-positive Diagnosis of CLL that meets 2008 the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria, must have at least one of the following criteria.
Refractory disease is defined as failure to achieve a response after 6 cycles of induction chemotherapy or having disease progression within 6 months of the last treatment.
Adequate organ function defined as:
Exclusion Criteria:
The patient's heart fits any of the following conditions:
Left Ventricular Ejection Fraction (LVEF) ≤45%; III/IV congestive heart failure (NYHA); Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia); corrected QT interval (QTc)≥450ms (male)or QTc≥470ms (female)(QTc using Bazett's(QTcB)=QT/RR^0.5); Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery.
Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
Contact: Chuanli Zhao, Dr. | +86 185 6008 7009 | chuanlizhao@163.com |
China, Shandong | |
Qilu Hospital of Shandong University | Recruiting |
Jinan, Shandong, China, 250012 | |
Contact: Chuanli Zhao, Dr. +86 185 6008 7009 chuanlizhao@163.com | |
Principal Investigator: Chunyan Ji, Dr. |
Tracking Information | |||||
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First Submitted Date ICMJE | July 3, 2019 | ||||
First Posted Date ICMJE | July 8, 2019 | ||||
Last Update Posted Date | July 8, 2019 | ||||
Estimated Study Start Date ICMJE | July 2019 | ||||
Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Clinical Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (CNCT19) in the Treatment of Cluster of Differentiation 19 (CD19) Positive Relapsed or Refractory B Cell Malignancies | ||||
Official Title ICMJE | A Clinical Study of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory B Cell Malignancies | ||||
Brief Summary | This is a single arm, open-label, single center study to determine the safety and efficacy of CNCT19 in adult patients with Relapsed or Refractory B cell Malignancies. | ||||
Detailed Description | This is a single arm, open-label, single-center study to determine the safety and efficacy of CNCT19 in adult patients with r/r B cell Malignancies. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19 cell infusion. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Early Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Relapsed or Refractory Hematological Malignancies | ||||
Intervention ICMJE | Biological: CNCT19
0.5 to 4 x 10^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10^8 autologous CNCT19 transduced cells via intravenous infusion.
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Study Arms ICMJE | Experimental: A
Single dose of CNCT19
Intervention: Biological: CNCT19
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 2022 | ||||
Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04011293 | ||||
Other Study ID Numbers ICMJE | HY001003 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Chunyan Ji, Shandong University | ||||
Study Sponsor ICMJE | Shandong University | ||||
Collaborators ICMJE | Juventas Cell Therapy Ltd. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Shandong University | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |