CD70.CAR NK Cells for Lymphoma

This study is testing a new cell therapy called CD70.CAR NK Cells for people with diffuse large B-cell lymphoma (DLBCL) or Hodgkin lymphoma (HL). These are types of cancer that affect white blood cells. You might be able to join if your lymphoma has not responded to initial treatment (primary refractory) or came back within 12 months (early relapsed). Before receiving the CD70.CAR NK Cells, you will get other medications called Fludarabine and Cyclophosphamide, and also Rimiducid (AP1903). Researchers want to see how safe this treatment is and if it can help control the cancer. To be eligible, your tumor must show a certain level of CD70, a protein, as detected by a biopsy.

Study design
This is an interventional study planning to enroll 100 participants. It is testing the CD70.CAR NK cell therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

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NCT07164469

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

Not Yet Recruiting
PHASE2Ages 18–75InterventionalTreatment
M.D. Anderson Cancer Center
~100 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamideCD70.CAR NK CellsRimiducid (AP1903)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Large B-cell Lymphoma
Hodgkin Lymphoma
1 sites across 1 states
Texas1
  • Yago Nieto, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. 3. Tumor biopsy positive for CD70 \>/= 10% by immunohistochemistry or flow cytometry. 4. Measurable disease, defined by one or more histologically confirmed hypermetabolic lesion on PET/CT scan. 5. ECOG PS ≤ 2 (Karnofsky ≥60%). 6. Adequate blood counts (WBC \> 2K, HGB \> 8 g/dL, platelets \> 50K). 7. Creatinine clearance ≥ 30 ml/min. 8. ALT and/or AST ≤ 3 x ULN, and bilirubin and ALP ≤ 2 x ULN. 9. FEV1, FVC and DLCOc ≥ 50%. 10. LVEF ≥40%, without active arrythmias. 11. 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. 12. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 13. 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. 14. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 15. 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. 16. 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.
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. 18. Ability to understand and the willingness to sign a written informed consent document. 19. Agree to sign consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies.
  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

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