CRISPR (HPK1) Edited CD19-specific CAR-T Cells (XYF19 CAR-T Cells) for CD19+ Leukemia or Lymphoma.
|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: NCT04037566|
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphocytic Acute (ALL) in Relapse Leukemia Lymphocytic Acute (All) Refractory Lymphoma, B-Cell CD19 Positive||Genetic: XYF19 CAR-T cell Drug: Cyclophosphamide Drug: Fludarabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety Study of Autologous T Cells Engineered to Target CD19 and CRISPR Gene Edited to Eliminate Endogenous HPK1 (XYF19 CAR-T Cells) for Relapsed or Refractory Haematopoietic Malignancies.|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2024|
Experimental: XYF19 CAR-T cell
One arm study consisting of "3 + 3" dose escalation study design followed by dose expansion phase at determined MTD.
Genetic: XYF19 CAR-T cell
Autologous T cells engineered to specify CD19 transduced with a lentiviral vector and electroporated with CRISPR guide RNA to disrupt expression of endogenous HPK1 administered by IV injection.
A cytotoxic chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells.
A chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells.
- The adverse events associated with XYF19 CAR-T cells product will be assessed. [ Time Frame: 30 days ]Determine safety profile of a single infusion of XYF19 CAR-T cells by monitoring the frequency and severity of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Occurrence of study related adverse events defined as NCI CTCAE v5.0 > grade 3 possibly, probably, or definitely related to study treatment. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event.
- Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT). [ Time Frame: 30 days ]The MTD is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT). The dose limiting toxicity is defined as CTCAE grades non-reversible grade 3, or any grade 4-5 allergic reactions related to the study cell infusion; CTCAE grades non-reversible grade 3, or any grade 4-5 autoimmune reactions related to the study cell infusion; or CTCAE grades non-reversible non-hematologic grade 3, or any grade 4-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy and occurring within 30 days of study product infusion related to study cell infusion. The study will employ a standard 3+3 design to find the MTD of XYF19 CAR-T cells dose.
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): NCT04037566
|Contact: Guangxun GAO, Dr.||+86 29 email@example.com|
|Contact: Yu WANG, Dr.||+86 29 firstname.lastname@example.org|
|Xi'an, Shannxi, China, 710032|
|Contact: Guangxun GAO, Dr. +86 29 84775203 email@example.com|
|Contact: Yu WANG, Dr. +86 29 88764122 firstname.lastname@example.org|
|Principal Investigator:||Guangxun GAO, Dr.||Xijing Hospital|