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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

ConditionsB-Cell LymphomaMyelodysplastic Syndromes (MDS)Acute Myeloid Leukemia (AML)Multiple MyelomaPlasma Cell LeukemiaHodgkin LymphomaT-cell Non-Hodgkin's Lymphoma/ T-cell Acute Lymphoblastic LeukmeiaMyelodysplastic Syndrome / Chronic Myelomonocytic LeukemiaBlastic Transformation of Chronic Myeloid LeukemiaGerm Cell Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-80
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.

Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.

Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.

HIV with detectable viral load

Trial design

Design model

Single group

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    Given by IV

  • CAR.70/IL15-transduced CB-NK cells

    Drug

    Given by IV

  • Fludarabine phosphate

    Drug

    Given by IV

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: CyclophosphamideExperimental treatment 2 interventions
Group B: CAR.70/IL15-transduced CB-NK cellsExperimental treatment 1 intervention
Group C: Fludarabine phosphateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
through study completion, an average of 1 year
2

Number of Participants with Complete or Partial Response

Time frame
Up to 30 days after the last treatment
3

Number of Participants who are Alive and in Remission

Number of Participants who are Alive and in Remission after 6 months.

Time frame
Up to 180 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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