Trials / Recruiting
RecruitingNCT05092451
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 12 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma. Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.
Detailed description
Primary Objective: To determine the safety, efficacy and optimal cell dose of CAR.70/IL15-transduced CB-NK cells in patients with relapsed/refractory hematological malignances. The efficacy and optimal dose will be identified for individual diseases. Secondary Objectives: * To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient. * To conduct comprehensive immune reconstitution studies.
Conditions
- B-Cell Lymphoma
- Myelodysplastic Syndromes (MDS)
- Acute Myeloid Leukemia (AML)
- Multiple Myeloma
- Plasma Cell Leukemia
- Hodgkin Lymphoma
- T-cell Non-Hodgkin's Lymphoma/ T-cell Acute Lymphoblastic Leukmeia
- Myelodysplastic Syndrome / Chronic Myelomonocytic Leukemia
- Blastic Transformation of Chronic Myeloid Leukemia
- Germ Cell Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide | Given by IV |
| DRUG | CAR.70/IL15-transduced CB-NK cells | Given by IV |
| DRUG | Fludarabine phosphate | Given by IV |
Timeline
- Start date
- 2022-11-01
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
- First posted
- 2021-10-25
- Last updated
- 2026-03-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05092451. Inclusion in this directory is not an endorsement.