Study of Anti-CD70 CAR T-Cell Therapy for CD70-Expressing Cancers
This study is testing a new approach for cancers that express a protein called CD70, including pancreatic, kidney, breast, melanoma, and ovarian cancers. Researchers take your own white blood cells, modify them in the lab to recognize CD70 (these are called Anti-hCD70 CAR transduced PBL), and then give them back to you. Before receiving these cells, you will get chemotherapy drugs, Cyclophosphamide and Fludarabine, and a drug called Aldesleukin. The main goals are to see if this treatment is safe, what side effects it might cause, and if it can shrink tumors. You may be eligible if you are an adult between 18 and 72 with an unresectable cancer that has progressed after standard treatments and expresses CD70.
- Study design
- This is a Phase I/II study, meaning it first checks for safety and then for effectiveness. It's a single-center study aiming to enroll up to 124 participants.
- What's involved
- You will undergo screening with medical history, physical exams, and scans. You will have a procedure called leukapheresis to collect your blood cells, and then receive the study drugs and modified cells intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be checked at 6 and 12 weeks, then every 3 months for a year, then every 6 months for two years, and then as decided by the doctor.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT02830724
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Recruiting
PHASE1Ages 18–72InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~124 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabineAldesleukinAnti-hCD70 CAR transduced PBL
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of treatment-related adverse events
Measured over From time of cell infusion to two weeks after cell infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- James C Yang, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
For Phase I: Evaluable, unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).
For Phase II: Measurable (per RECIST v1.1 criteria), unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).
Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.
Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred.
Patients with 3 or fewer brain metastases that are less than or equal to 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
Age greater than or equal to 18 years and less than or equal to 72 years.
Clinical performance status of ECOG 0 or 1
Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for women and for four months after treatment for men.
Women of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.
Serology
Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
Hematology
ANC greater than 1000/mm(3) without the support of filgrastim
WBC greater than or equal to 2500/mm(3)
Platelet count greater than or equal to 80,000/mm(3)
Hemoglobin \> 8.0 g/dL. Subjects may be transfused to reach this cut-off.
Chemistry
Serum ALT/AST less than or equal to 5.0 times ULN
Serum creatinine less than or equal to 1.6 mg/dL
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL.
Patients must have completed any prior systemic therapy at the time of enrollment.
Ability of subject to understand and the willingness to sign a written informed consent document.
Willing to sign a durable power of attorney.
Subjects must be co-enrolled on the NCI-SB cell harvest protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).
Exclusion
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
Concurrent systemic steroid therapy.
Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
History of hematopoietic autoimmune disease or any autoimmune disease requiring immunosuppressive measures.
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
History of coronary revascularization or ischemic symptoms.
For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.
For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.
Patients who are receiving any other investigational agents.
What this trial measures
- Frequency and severity of treatment-related adverse eventsFrom time of cell infusion to two weeks after cell infusion
Grade and type of toxicity per dose level; fraction of patients who experience a DLT at a given dose level, and number and grade of each type of DLT
- Response rate6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per PI discretion
Percentage of patients who have a clinical response (PR+CR) to treatment (objective tumor regression)