Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances
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ClinicalTrials.gov Identifier: NCT05110742 |
Recruitment Status :
Recruiting
First Posted : November 8, 2021
Last Update Posted : April 24, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | September 28, 2021 | ||||
First Posted Date ICMJE | November 8, 2021 | ||||
Last Update Posted Date | April 24, 2024 | ||||
Actual Study Start Date ICMJE | April 22, 2024 | ||||
Estimated Primary Completion Date | December 30, 2026 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0. [ Time Frame: through study completion, an average of 1 year ] General grading:
Grade 1: Mild: discomfort present with no disruption of daily activity, no treatment required beyond prophylaxis.
Grade 2: Moderate: discomfort present with some disruption of daily activity, require treatment.
Grade 3: Severe: discomfort that interrupts normal daily activity, not responding to first line treatment.
Grade 4: Life Threatening: discomfort that represents immediate risk of death
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances | ||||
Official Title ICMJE | Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances | ||||
Brief Summary | To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases. | ||||
Detailed Description | Primary objective: To determine the safety, efficacy and optimal cell dose of CAR.5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases. Secondary Objectives:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hematological Malignancy | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 |
48 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2027 | ||||
Estimated Primary Completion Date | December 30, 2026 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria
1. Patients with history of T-lymphoid malignancies, defined as acute lymphoblastic leukemia (ALL/T-LBL), Peripheral T-cell lymphoma (PTCL-NOS, MF/SS, Hepatosplenic gamma/delta NHL, AITL, ALCL) who have received at least 2 lines of standard chemo-immunotherapy or targeted therapy and have measurable persistent disease. For T-ALL active disease defined as (>5% of blasts or positive MRD at a level of >0.1% measured by multiparameter flow cytometry). 2. Patients with history of T-lymphoid malignancies as defined above with relapsed disease following standard therapy or a stem cell transplant. B. Chronic lymphocytic leukemia (CLL) Chronic lymphocytic leukemia (CLL) small lymphocytic lymphoma (SLL), Richter's transformation of CLL or SLL who have received at least 2 lines of standard chemoimmunotherapy or targeted therapy and have persistent disease C. Mantle cell lymphoma Relapsed or refractory mantle cell lymphoma after 2 lines of standard chemoimmunotherapy including a BTKi 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 | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05110742 | ||||
Other Study ID Numbers ICMJE | 2021-0526 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | M.D. Anderson Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |