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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-12093 | Other Identifier | NCI-CTRP Clinical Trials Reporting |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclophosphamide | Experimental | Cyclophosphamide is dosed per adjusted body weight for patients weighing > 20% above their ideal body weight using the calculation. |
|
| CAR.70/IL15-transduced CB-NK cells | Experimental | Patients will receive a single flat dose of CAR-NK. |
|
| Fludarabine phosphate | Experimental | Fludarabine is dosed using actual body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Given by IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0. | CTCAE Version 5.0 - 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 | through study completion, an average of 1 year |
| Number of Participants with Complete or Partial Response | Up to 30 days after the last treatment | |
| Number of Participants who are Alive and in Remission | Number of Participants who are Alive and in Remission after 6 months. | Up to 180 days |
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Inclusion criteria:
Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry.
Patients must meet diseases specific eligibility criteria (see below)
Patients at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML, CML, and MDS patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until up to three days prior to administration of lymphodepleting chemotherapy.
Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated to assess response
Karnofsky Performance Scale > 50% for patients who are >16 years old or Lansky score ≥50% for patients who are ≤16 years of age.
Adequate organ function:
Able to provide written informed consent.
12-80 years of age.
Weight ≥40 kg
All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.
Signed consent to long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.
Are willing and able to provide informed consent, as appropriate (either directly or through a legally authorized representative [LAR])
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Marin | Contact | (713) 792-4179 | dmarin@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| David Marin, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41144785 | Derived | Lin P, Acharya S, Reyes-Silva F, Basar R, Uprety N, Moreno Rueda LY, Lin P, Gilbert AL, Banerjee PP, Fang D, Zhang C, Nunez Cortes AK, Melo Garcia L, Daher M, Muniz-Feliciano L, Deyter GM, Woods V, Rawal S, Li P, Jones CM, Shrestha R, Qazilbash MH, Patel KK, Lee HC, Champlin RE, Marin D, Shpall EJ, Orlowski RZ, Rezvani K. CD70-Targeting CAR NK Cells Overcome BCMA Downregulation and Improve Survival in High-risk Multiple Myeloma Models. Blood Cancer Discov. 2026 Mar 4;7(2):234-249. doi: 10.1158/2643-3230.BCD-25-0130. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| CAR.70/IL15-transduced CB-NK cells | Drug | Given by IV |
|
| Fludarabine phosphate | Drug | Given by IV |
|
|
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D009101 | Multiple Myeloma |
| D007952 | Leukemia, Plasma Cell |
| D006689 | Hodgkin Disease |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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