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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05092451
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)
  • B-Cell Lymphoma
  • Blastic Transformation of Chronic Myeloid Leukemia
  • Germ Cell Tumors
  • Hodgkin Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndrome / Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndromes (MDS)
  • Plasma Cell Leukemia
  • T-cell Non-Hodgkin's Lymphoma/ T-cell Acute Lymphoblastic Leukmeia

Eligibility Criteria

Sex
ALL
Age
12 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given by IV
  • CAR.70/IL15-transduced CB-NK cells — DRUG
    Given by IV
  • Fludarabine phosphate — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
David Marin, MD
[email protected]
713-792-4179
David Marin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
M D Anderson Cancer Center· Houston, TX

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