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B-Cell LymphomaPhase 1/2NCT05092451

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

A Phase 1/2 study testing Cyclophosphamide, CAR.70/IL15-transduced CB-NK cells and Fludarabine phosphate in people with B-Cell Lymphoma and Myelodysplastic Syndromes (MDS), run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 80 years
What is being tested?
Cyclophosphamide, CAR.70/IL15-transduced CB-NK cells and Fludarabine phosphate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Nov 2022to 31 Aug 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
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  • 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])

Who cannot join

  • 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
  • Presence of active neurological disorder(s).
  • Active autoimmune disease within 12 months of enrollment
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  • Amyloidosis or POEMS syndrome
  • Active cerebral or meningeal involvement by the malignancy
  • Active (defined as requiring therapy) acute or chronic GVHD
  • Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
  • Presence of any other serious medical condition that may endanger the patient at investigator discretion.
  • Major surgery <4 weeks prior to first dose of the preparatory chemotherapy
  • Allogeneic SCT or DLI <12 weeks prior to first dose of preparatory chemotherapy
  • Concomitant use of other investigational agents.
  • Concomitant use of other anti-cancer agents.
  • Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.
  • Patients receiving immunosuppressive therapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Marin contact

(713) 792-4179

dmarin@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    David Marin, MD, 713-792-4179, dmarin@mdanderson.org

    David Marin, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.
Being tested
Cyclophosphamide, CAR.70/IL15-transduced CB-NK cells, Fludarabine phosphate
Medical subject headings
Lymphoma, B-Cell, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Multiple Myeloma, Leukemia, Plasma Cell, Hodgkin Disease, Leukemia, Myelomonocytic, Chronic, Neoplasms, Germ Cell and Embryonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05092451
Study groupRoleWhat they receive
CyclophosphamideExperimentalCyclophosphamide is dosed per adjusted body weight for patients weighing > 20% above their ideal body weight using the calculation.
Receives: Drug: Cyclophosphamide; Drug: Fludarabine phosphate
CAR.70/IL15-transduced CB-NK cellsExperimentalPatients will receive a single flat dose of CAR-NK.
Receives: Drug: CAR.70/IL15-transduced CB-NK cells
Fludarabine phosphateExperimentalFludarabine is dosed using actual body weight.
Receives: Drug: Cyclophosphamide; Drug: Fludarabine phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: through study completion, an average of 1 year

  2. Number of Participants with Complete or Partial Response

    Measured: 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.

    Measured: Up to 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start1 Nov 2022
  3. Primary completion31 Aug 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05092451
Sponsor's protocol ID
2021-0386
Other IDs
NCI-2021-12093
Status last verified
Aug 2026
First submitted
13 Oct 2021
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 41144785

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cyclophosphamide, CAR.70/IL15-transduced CB-NK cells and Fludarabine phosphate in people with B-Cell Lymphoma and Myelodysplastic Syndromes (MDS), run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Marin ((713) 792-4179, dmarin@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05092451, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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