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

Who is this study for? Patients with relapsed/refractory hematological malignances
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 80
Healthy Volunteers: f
View:

• 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:

∙ Renal: Serum creatinine \</= 2x ULN or estimated Glomerular Filtration Rate \>/= 30 ml/min/1.73 m2

‣ Hepatic: ALT/AST \</= 3 x ULN or \</= 5 x ULN if documented liver metastases, Total bilirubin \</2xULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be \</= 3 x.ULN. No history of liver cirrhosis. No ascites.

‣ Cardiac: Cardiac ejection fraction \>/= 40%, no clinically significant pericardial effusion as determined by an ECHO, and no uncontrolled arrhythmias or symptomatic cardiac disease.

‣ Pulmonary: No clinically significant pleural effusion (per PI discretion), baseline oxygen saturation \> 92% on room air and adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) \>50%.

• 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 \[LAR\])

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
David Marin
dmarin@mdanderson.org
(713) 792-4179
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 80
Treatments
Experimental: Cyclophosphamide
Cyclophosphamide is dosed per adjusted body weight for patients weighing \> 20% above their ideal body weight using the calculation.
Experimental: CAR.70/IL15-transduced CB-NK cells
Patients will receive a single flat dose of CAR-NK.
Experimental: Fludarabine phosphate
Fludarabine is dosed using actual body weight.
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov

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