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LymphoidPhase 1NCT07444632

Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies

A Phase 1 study testing Fludarabine, TGFBR2 KO CAR27/IL-15 NK cells and Cyclophosphamide in people with Lymphoid and Hodgkin Lymphoma, 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

This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lymphoid, Hodgkin Lymphoma
What is being tested?
Fludarabine, TGFBR2 KO CAR27/IL-15 NK cells and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
28 May 2026to 30 Sep 2032
Phase
Phase 1
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 relapsed B-NHL, HL, T-NHL, or B-ALL in refractory relapse, defined as:
  • B-NHL: Failure of >/= 1 salvage line and failure of or ineligibility for CAR-T.
  • HL and T-NHL: Failure of >/= 1 salvage line or prior SCT.
  • ALL: Active disease (>5% of blasts or positive MRD at a level of >0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy. Patients with B-ALL must have either failed of or be ineligible for CAR-T cell therapy. Patients who have mutations for which there are FDA approved targeted therapies (i.e., BCR-ABL) must also have received at least one of such agents.
  • Expression of CD70 in the pre-enrollment sample >/= 20% measured by immunohistochemistry or flow cytometry.
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  • Measurable disease, defined by >/= 1 histologically confirmed hypermetabolic lesion on PET/CT scan.
  • 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 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 still 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 child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence, see Appendix 1) 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 (see Appendix 1) 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 willingness to sign a written informed document.
  • Agree to sign consent to the long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.

Who cannot join

  • Lymphoma or ALL 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 mightincrease the risk associated with study participation.
  • Any other malignancy known to be active, with the exception of treated cervical intraepithelial neoplasia and non-melanoma skincancer.
  • Grade >/= 3 non-hematologic toxicity from prior therapy that has notimproved to grade </= 2.
  • Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR).
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  • Active infection requiring parenteral antibiotics.
  • HIV infection.
  • Treatment within prior 2 weeks with any anti-cancer agent,investigational or approved.
  • Active 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.
  • Patients who are receiving any other investigational agents.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.

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, 1 recruiting

  • 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

    Recruiting

Other trials in United States

About this study

This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.

Read the detailed description

Primary Objective:

To establish the safety of TGFBR2 KO CAR27/IL-15 NK cells in patients with R/R lymphomas and B-ALL through the following primary endpoints

  • To determine the recommended phase 2 dose (RP2D) of this treatment.
  • To define the dose-limiting toxicity (DLT) of this treatment.

Secondary Objectives:

  1. To observe and record anti-tumor activity through the following secondary endpoints:
  • Day+ 30 complete response (CR) rate.
  • Day +30 overall response rate (ORR).
  • Day 180 progression-free survival rate
  1. To quantify the persistence of infused donor TGFBR2 KO CAR27/IL-15 NK cells in the recipient.
  2. To conduct comprehensive immune reconstitution studies.
  3. To obtain preliminary data on quality of life (QOL) and patient experience
Being tested
Fludarabine, TGFBR2 KO CAR27/IL-15 NK cells, Cyclophosphamide
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

  • TGFBR2 KO CAR27/IL-15 NK cellsDrug

    Given by IV

  • CyclophosphamideDrug

    Also called Cytoxan

    Given by IV

Study groups in NCT07444632
Study groupRoleWhat they receive
Cycle 1: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK CellsExperimentalEach treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.
Receives: Drug: Fludarabine; Drug: TGFBR2 KO CAR27/IL-15 NK cells; Drug: Cyclophosphamide
Cycle 2: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK CellsExperimentalEach treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.
Receives: Drug: Fludarabine; Drug: TGFBR2 KO CAR27/IL-15 NK cells; Drug: Cyclophosphamide

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 posted3 Mar 2026
  2. Study start28 May 2026
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion30 Sep 2032 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07444632
Sponsor's protocol ID
2025-1398
Other IDs
NCI-2026-01395
Status last verified
Sep 2026
First submitted
26 Feb 2026
Last updated
8 Sep 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 1 study testing Fludarabine, TGFBR2 KO CAR27/IL-15 NK cells and Cyclophosphamide in people with Lymphoid 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 30 inclusion and 16 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 8 Sep 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 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.

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 NCT07444632.

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 8 Sep 2026.

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