Clear Cell Renal Cell CarcinomaPhase 1NCT06480565
A Phase 1 Trial of ADI-270 in ccRCC
A Phase 1 study testing ADI-270, Fludarabine and Cyclophosphamide in people with Clear Cell Renal Cell Carcinoma, run by Adicet Therapeutics at 1 site in United States.
Trial summary
This is a Phase 1 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor [CAR] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- ADI-270, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 22 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed clear cell RCC
- Documented evidence of advanced or metastatic diseases.
- Patients must have been treated with an immune checkpoint inhibitor and a VEGF inhibitor (the VEGF inhibitor must have been administered in the advanced and/or metastatic setting).
- At least one measurable target lesion according to RECIST 1.1
- At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy
- KPS ≥ 70
Who cannot join
- Subjects with CNS metastases or spinal cord compression are not eligible, unless they have completed therapy and have discontinued the use of corticosteroids for at least 8 weeks and remained stable prior to enrollment.
- Clinically significant CNS dysfunction of any etiology in the opinion of the Investigator.
- Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions (palliative radiotherapy to bone lesions must be completed at least 2 weeks prior to the first dose of LD).
- Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months
- Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks before initiating LD in this study.
- Receipt of CD70 targeted therapies for any indication
Show all 9Show fewer
- Require corticosteroid therapy > 5 mg per day of prednisone or equivalent.
- History of any form of primary immunodeficiency such as severe combined immunodeficiency disease.
- Presence of active autoimmune disease requiring ongoing systemic immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Adicet Clinical Trials
Redwood City, California, 94065
About this study
Official title: A Phase 1 Trial of ADI-270 (Engineered γδ Chimeric Receptor [CAR] Vδ1 T Cells Targeting CD70) in Adults With Relapsed or Refractory (R/R) Clear Cell Renal Cell Carcinoma (ccRCC)
This is a Phase 1 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor [CAR] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- ADI-270, Fludarabine, Cyclophosphamide
- Keywords
- Renal cell carcinoma, cell therapy, CD70, chimeric antigen receptor (CAR) t-cell therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-270Drug
Anti-CD70 CAR-T
FludarabineDrug
Chemotherapy for Lymphodepeletion
CyclophosphamideDrug
Chemotherapy for Lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | ADI-270 is administered at ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-270 Receives: Drug: ADI-270; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Expansion | Experimental | Dose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2). Receives: Drug: ADI-270; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)
Measured: Day 28
Proportion of treatment emergent and treatment related adverse events
This primary endpoint will be used to determine the MTD/MAD of ADI-270
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start12 Dec 2024
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 Dose Escalation Design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adicet Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480565
- Sponsor's protocol ID
- ADI-202427001
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nishimoto KP, Lamture G, Chanthery Y, Teague AG, Verma Y, Au M, Smith-Boeck M, Salum M, Murthy P, Gundurao SRY, Kaur R, Zhang J, Azameera A, Wong JTS, Speltz EB, Wang KM, Doan A, Sethuraman J, Bhatwala D, Giner-Rubio A, Puligujja P, Budworth H, Rold CJ, Panuganti S, Jakobovits A, Herrman M, Bhat A, Green S, Aftab BT. ADI-270: an armored allogeneic gamma delta T cell therapy designed to target CD70-expressing solid and hematologic malignancies. J Immunother Cancer. 2025 Jul 1;13(7):e011704. doi: 10.1136/jitc-2025-011704.
PubMed 40592738
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of ADI-270 (Engineered γδ Chimeric Receptor [CAR] Vδ1 T Cells Targeting CD70) in Adults With Relapsed or Refractory (R/R) Clear Cell Renal Cell Carcinoma (ccRCC)
- ClinicalTrials.gov ID
- NCT06480565
- Acronym / sponsor ID
- ADI-202427001
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- Renal cell carcinoma, cell therapy, CD70, chimeric antigen receptor (CAR) t-cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Adicet TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor [CAR] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3+3 Dose Escalation Design
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: ADI-270, Drug: Fludarabine, Drug: CyclophosphamideADI-270 is administered at ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-270 |
| Dose Expansion | Experimental | Drug: ADI-270, Drug: Fludarabine, Drug: CyclophosphamideDose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed clear cell RCC
- Documented evidence of advanced or metastatic diseases.
- Patients must have been treated with an immune checkpoint inhibitor and a VEGF inhibitor (the VEGF inhibitor must have been administered in the advanced and/or metastatic setting).
- At least one measurable target lesion according to RECIST 1.1
- At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy
Key exclusion criteria (9 listed)
- Subjects with CNS metastases or spinal cord compression are not eligible, unless they have completed therapy and have discontinued the use of corticosteroids for at least 8 weeks and remained stable prior to enrollment.
- Clinically significant CNS dysfunction of any etiology in the opinion of the Investigator.
- Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions (palliative radiotherapy to bone lesions must be completed at least 2 weeks prior to the first dose of LD).
- Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months
- Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks before initiating LD in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-270Anti-CD70 CAR-T | Drug | Dose Escalation, Dose Expansion |
| FludarabineChemotherapy for Lymphodepeletion | Drug | Dose Escalation, Dose Expansion |
| CyclophosphamideChemotherapy for Lymphodepletion | Drug | Dose Escalation, Dose Expansion |
Primary outcome
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: Day 28
This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)
Proportion of treatment emergent and treatment related adverse events
Time frame: 2 years
This primary endpoint will be used to determine the MTD/MAD of ADI-270
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 40592738Nishimoto KP, Lamture G, Chanthery Y, Teague AG, Verma Y, Au M, Smith-Boeck M, Salum M, Murthy P, Gundurao SRY, Kaur R, Zhang J, Azameera A, Wong JTS, Speltz EB, Wang KM, Doan A, Sethuraman J, Bhatwala D, Giner-Rubio A, Puligujja P, Budworth H, Rold CJ, Panuganti S, Jakobovits A, Herrman M, Bhat A, Green S, Aftab BT. ADI-270: an armored allogeneic gamma delta T cell therapy designed to target CD70-expressing solid and hematologic malignancies. J Immunother Cancer. 2025 Jul 1;13(7):e011704. doi: 10.1136/jitc-2025-011704.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADI-270, Fludarabine and Cyclophosphamide in people with Clear Cell Renal Cell Carcinoma, run by Adicet Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.