Phase 1/2 of ADI-270 in adults with R/R ccRCC (Clear Cell Renal Cell Carcinoma)

Phase 1/2 of ADI-270 in adults with R/R ccRCC (Clear Cell Renal Cell Carcinoma)

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Purpose of this Study

We are doing this study to find out if an experimental drug called ADI-270 (the study drug) is a safe and effective option for patients with clear cell renal cell carcinoma that has come back after treatment or is not responding to treatment.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with clear cell renal cell carcinoma
  • Have disease that has come back after treatment (relapsed) or is not adequately responding to treatment(refractory)
For more information, contact the study team at ryan.woelfel@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

The study is divided into several parts: screening period, lymphodepletion period, study drug period, re-dosing period, and a follow-up period. During the screening period, you will:
  • Visit our clinic a few times over a period of 3-8 weeks to confirm your eligibility to join
  • Have a biopsy
  • Have blood draws and give urine samples
  • Have imaging scans (PET and/or CT)
  • Have heart scans (EKGs and and echocardiogram)
If you are found to be eligible, you will proceed to the lymphodepletion period. During this period, you will be treated with a combination of the drugs fludarabine (or bendamustine) and cyclophosphamide. You will get these drugs by intravenous (IV) infusion on 3 consecutive days. You will then proceed to the study drug period 3 days after you get your last dose of these drugs. During the study drug period, you will get a single dose of the study drug. You will check into the hospital the day before the study drug dosing, and you will stay for 7 days afterward. You will return for 6 check-up visits in the first 3 weeks after you check out of the hospital. If the study doctor believes that you would benefit from another dose of the drug, you will proceed to the re-dosing period. The procedures during the re-dosing period will be the same as those from the first dosing period. After the check-up visits from your last dose of the study drug are finished, you will proceed to the follow-up period. During this period, you will visit our clinic for follow-up visits 2 times in the first year of the follow-up period, and then every 3 months for the second year of the follow-up period.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Phase 1/2 Trial of ADI-270 (Engineered Chimeric Receptor [CAR] T Cells
Targeting CD70) in Adults with Relapsed or Refractory (R/R) Clear Cell Renal Cell
Carcinoma (ccRCC)

Principal Investigator

Christopher
Hoimes

Protocol Number

PRO00117484

NCT ID

NCT06480565

Phase

II

Enrollment Status

Pending Open to Enrollment