Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma
2 other identifiers
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2026
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedStudy Start
First participant enrolled
June 28, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2031
Study Completion
Last participant's last visit for all outcomes
September 30, 2033
May 6, 2026
May 1, 2026
5.3 years
September 4, 2025
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (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
Through study completion; an average of 1 year
Study Arms (2)
1st Dose: Treatment with Rimiducid + CD70.CAR NK Cells for Patients with DLBCL and HL
EXPERIMENTALPatients 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.
2nd Dose: Treatment with Rimiducid + CD70.CAR NK Cells for Patients with DLBCL and HL
EXPERIMENTALPatients 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.
Interventions
Given by IV
Given by IV
Given by IV Infusion
Given by IV Infusion
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +9 more criteria
You may not qualify if:
- 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
- \>/=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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Bellicum Pharmaceuticalscollaborator
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yago Nieto, MD,PHD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2025
First Posted
September 10, 2025
Study Start (Estimated)
June 28, 2026
Primary Completion (Estimated)
September 30, 2031
Study Completion (Estimated)
September 30, 2033
Last Updated
May 6, 2026
Record last verified: 2026-05