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Large B-cell LymphomaPhase 2NCT07164469

Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma

A Phase 2 study testing Fludarabine, Cyclophosphamide and CD70.CAR NK Cells in people with Large B-cell Lymphoma and Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This clinical research study is to learn if CD70.CAR NK cell therapy can help to control early relapsed or primary refractory DLBCL and cHL. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Large B-cell Lymphoma, Hodgkin Lymphoma
What is being tested?
Fludarabine, Cyclophosphamide and CD70.CAR NK Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
28 Dec 2026to 30 Sep 2033
Phase
Phase 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years of age.
  • Diagnosis of cHL or DLBCL that is either:
  • Primary refractory, defined as not having achieved a CR with frontline therapy or having relapsed within 3 months.
  • Early relapsed (≤ 12 months) after achieving a CR to frontline therapy.
  • Tumor biopsy positive for CD70 >/= 10% by immunohistochemistry or flow cytometry.
  • Measurable disease, defined by one or more histologically confirmed hypermetabolic lesion on PET/CT scan.
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  • ECOG PS ≤ 2 (Karnofsky ≥60%).
  • Adequate blood counts (WBC > 2K, HGB > 8 g/dL, platelets > 50K).
  • Creatinine clearance ≥ 30 ml/min.
  • ALT and/or AST ≤ 3 x ULN, and bilirubin and ALP ≤ 2 x ULN.
  • FEV1, FVC and DLCOc ≥ 50%.
  • LVEF ≥40%, without active arrythmias.
  • If female of child-bearing potential, she must not be pregnant or breastfeeding and is required to have a negative urine or serum pregnancy test prior to enrollment.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
  • To be eligible for this trial, patients should be class 2B or better.
  • The effects of CAR-NK cells on the developing human fetus are unknown. For this reason and because fludarabine and cyclophosphamide, as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114).
  • This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CAR NK cell administration.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Agree to sign consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies.

Who cannot join

  • Lymphoma in CR with no measurable sites of disease.
  • Major surgery <4 weeks prior to first dose of study drug.
  • Any other severe or uncontrolled disease or condition which might increase the risk associated with study participation.
  • Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
  • Grade >/= 3 non-hematologic toxicity from prior therapy that has not improved to grade </= 2.
  • Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA
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  • >/=10,000 copies/mL, or >/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR).
  • Active infection requiring parenteral antibiotics.
  • HIV infection.
  • Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
  • Active central nervous system (CNS) involvement (untreatedparenchymal brain metastasis or positive cytology of cerebrospinal fluid).
  • Life expectancy </= 6 months.
  • Active and uncontrolled neurological disorder.
  • Patients receiving systemic steroid therapy at time of enrollment (physiological replacement 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.

Yago Nieto, MD,PHD contact

(713) 794-1752

ynieto@mdanderson.org

United States1 site

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030

    Yago Nieto, MD,PHD, 713-794-1752, ynieto@mdanderson.org

    Yago Nieto, MD,PHD

Other trials in United States

About this study

This clinical research study is to learn if CD70.CAR NK cell therapy can help to control early relapsed or primary refractory DLBCL and cHL.

Read the detailed description

Primary Objective:

The primary objective of the study is to determine the efficacy of CB-derived CD70.CAR NK cell therapy in patients with primary refractory or early relapsed DLBCL and HL, as determined by the 2-year event-free survival rate.

Secondary Objectives:

  • To determine the antitumor activity pf CB-derived CD70.CAR NK cells, as determined by the response rate (ORR) and complete response (CR) rate.
  • To establish the safety of this treatment.
  • To quantify the persistence of infused CB-derived CD70.CAR NK cells in the peripheral blood.
  • To conduct comprehensive immune studies by evaluating tissue and blood-based biomarkers associated with response and resistance to CD70.CAR NK cells.
Being tested
Fludarabine, Cyclophosphamide, CD70.CAR NK Cells, Rimiducid (AP1903)
Medical subject headings
Hodgkin Disease

What participants receive

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

  • FludarabineDrug

    Also called Fludara

    Given by IV

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar

    Given by IV

  • CD70.CAR NK CellsDrug

    Given by IV Infusion

  • Rimiducid (AP1903)Drug

    Given by IV Infusion

Study groups in NCT07164469
Study groupRoleWhat they receive
1st Dose: Treatment with Rimiducid + CD70.CAR NK Cells for Patients with DLBCL and HLExperimentalPatients will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide from days -5 to -3, prior to infusion of CD70.CAR NK cells on day 0, on an outpatient or inpatient as clinically indicated.
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: CD70.CAR NK Cells; Drug: Rimiducid (AP1903)
2nd Dose: Treatment with Rimiducid + CD70.CAR NK Cells for Patients with DLBCL and HLExperimentalPatients will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide from days -5 to -3, prior to infusion of CD70.CAR NK cells on day 0, on an outpatient or inpatient as clinically indicated.
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: CD70.CAR NK Cells; Drug: Rimiducid (AP1903)

What is being measured

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

  1. Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

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

  1. First posted10 Sep 2025
  2. Study start28 Dec 2026 (estimated)
  3. Primary completion30 Sep 2031 (estimated)
  4. Study completion30 Sep 2033 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07164469
Sponsor's protocol ID
2025-0986
Other IDs
NCI-2025-06569
Status last verified
Jul 2026
First submitted
4 Sep 2025
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine, Cyclophosphamide and CD70.CAR NK Cells in people with Large B-cell Lymphoma and Hodgkin Lymphoma, 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 25 inclusion and 15 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: opening soon, as of the sponsor's last update on 15 Jul 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 phase mean?

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 Yago Nieto, MD,PHD ((713) 794-1752, ynieto@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 NCT07164469.

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 15 Jul 2026.

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