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

NCT07164469•M.D. Anderson Cancer Center

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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-75 years of age.
•2. 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.
•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.
+13 more criteria

Exclusion Criteria

•1. Lymphoma in CR with no measurable sites of disease.
•2. Major surgery \<4 weeks prior to first dose of study drug.
•3. Any other severe or uncontrolled disease or condition which might increase the risk associated with study participation.
•4. Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
•5. Grade \>/= 3 non-hematologic toxicity from prior therapy that has not improved to grade \</= 2.
•6. 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).
•7. Active infection requiring parenteral antibiotics.
•8. HIV infection.
•9. Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
+5 more criteria

Locations (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

February 28, 2026

Primary Completion Date

September 30, 2031

Completion Date

September 30, 2033

Last Updated

March 11, 2026

Enrollment

100

ESTIMATED participants

Conditions

Large B-cell LymphomaHodgkin Lymphoma

Interventions

Fludarabine

DRUG

Cyclophosphamide

DRUG

CD70.CAR NK Cells

DRUG

Rimiducid (AP1903)

DRUG

Contacts

Yago Nieto, MD,PHD

CONTACT

(713) 794-1752 ynieto@mdanderson.org

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DLBCLDiffuse Large B-Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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