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

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

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.

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices