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Trial Title:
A Phase 1/2 Trial of ADI-270 in ccRCC
NCT ID:
NCT06480565
Condition:
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Cyclophosphamide
Fludarabine
Conditions: Keywords:
Renal cell carcinoma, cell therapy, CD70, chimeric antigen receptor (CAR) t-cell therapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
3+3 Dose Escalation Design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ADI-270
Description:
Anti-CD70 CAR-T
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Chemotherapy for Lymphodepeletion
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Chemotherapy for Lymphodepletion
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Summary:
This is a Phase 1/2 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed clear cell RCC
2. Documented evidence of advanced or metastatic diseases.
3. 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).
4. At least one measurable target lesion according to RECIST 1.1
5. At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of
the prior line of systemic therapy
6. KPS ≥ 70
Exclusion Criteria:
1. 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.
2. Clinically significant CNS dysfunction of any etiology in the opinion of the
Investigator.
3. 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).
4. 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
5. Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell
therapy within 6 weeks before initiating LD in this study.
6. Receipt of CD70 targeted therapies for any indication
7. Require corticosteroid therapy > 5 mg per day of prednisone or equivalent.
8. History of any form of primary immunodeficiency such as severe combined
immunodeficiency disease.
9. Presence of active autoimmune disease requiring ongoing systemic immunosuppressive
therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Adicet Therapeutics
Agency class:
Industry
Source:
Adicet Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06480565
