Safety and Efficacy Evaluation of CD19-UCART
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03229876|
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : April 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia (ALL) Non Hodgkin Lymphoma (NHL)||Biological: CD19-UCART||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Study of CD19-UCART (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor) in Patients With Relapsed or Refractory B-cell Hematologic Malignancies|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 15, 2022|
|Estimated Study Completion Date :||December 30, 2022|
All patients will be treated with 1 injection of CD19-UCART. Three escalating dose-levels (5x10^6/kgBW, 7x10^6/kgBW, 10x10^6/kgBW) of CD19-UCART will be evaluated using a 3+3 design. Each CD19-UCART injection will be administered at Day 0.
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy.
- Dose Limiting Toxicities (DLTs) occurence [ Time Frame: Baseline up to 35 days after T cell infusion ]Adverse events assessed according to NCI-CTCAE v4.03 criteria
- Objective Response Rate [ Time Frame: At 12 weeks, and overall ]Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed.
- Persistence of CART cells [ Time Frame: Assessed up to 3 months ]Duration of persistence of CD19-UCART cells after infusion will be detected by FACS or QPCR
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): NCT03229876
|Contact: Wei Li, phDfirstname.lastname@example.org|
|First Affliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Xinfeng Chen, PhD|
|Principal Investigator: Yi Zhang, Professor|
|First Affliated Hospital of Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310003|
|Contact: Yongxian Hu, Prof +8615957162012|
|Principal Investigator:||Yi Zhang, Professor||First Affliated Hospital of Zhengzhou University|
|Principal Investigator:||He Huang, Professor||First Affliated Hospital of Zhejiang University|