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A Phase 1 a/b Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 with Cyclophosphamide/Fludarabine Lymphodepletion alone or including ALLO-647 in Subjects with Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)
Cancer Categories
Genitourinary (GU)
Karmanos Trial ID
2023-070
NCT ID
NCT04696731
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Elisabeth
Heath, M.D., FACP
Oncology - Medical
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Objective:
Primary Objectives:
Phase 1a: Dose Escalation
To assess safety and tolerability at increasing dose levels of ALLO-316 in successive cohorts of subjects with advanced or metastatic ccRCC to estimate the maximum tolerated dose (MTD) of ALLO-316 administered following lymphodepletion and to select at least 1 Phase 1b expansion cohort dose regimen of ALLO-316.
To assess safety and tolerability of Flu and/or Cy in combination with or without ALLO-647 prior to ALLO-316
To assess safety and tolerability of other lymphodepletion regimens administered prior to ALLO-316, which may include cyclophosphamide/ALLO-647 (CA), fludarabine/ALLO-647 (FA), or ALLO-647 alone (A).
Phase 1b: Dose Expansion
To evaluate the safety, tolerability, and preliminary efficacy of ALLO-316 at the Phase 1b expansion cohort dose regimen, determine the recommended phase 2 regimen (RP2R), and evaluate the necessity of assessing CD70 expression in subject selection.
Secondary Objectives:
To evaluate the overall safety profile of ALLO-316 following lymphodepletion including or withholding ALLO-647).
To evaluate antitumor activity of ALLO-316.
To characterize cellular kinetics of ALLO-316.
To characterize the pharmacokinetics of ALLO-647.
To evaluate immunogenicity against ALLO-316 and ALLO-647.
To evaluate correlation of clinical outcomes with baseline tumor CD70 expression.
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Histologically confirmed renal cell carcinoma with a predominant clear cell component.
Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting.
At least one measurable lesion as defined by RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
Absence of donor (product)-specific anti-HLA antibodies (DSA).
Adequate hematological, renal, liver, pulmonary, and cardiac functions.
Exclusion Criteria:
Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression.
Clinically significant CNS dysfunction.
Any other active malignancy within 3 years prior to enrollment.
Prior treatment with anti-CD70 therapies.
Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy.
Prior treatment with anti-CD52 monoclonal antibody in the past 12 months.
Patients unwilling to participate in the extended safety monitoring period.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Kidney
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
CAR-T, Chemotherapy
Drugs
ALLO-316; ALLO-647; Cyclophosphamide; Fludarabine Phosphate
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