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AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

ConditionMetastatic Castration Resistant Prostate Cancer (mCRPC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorArsenal Biosciences, Inc.

About this trial

This is a multi-center, open-label Phase 1/2 trial evaluating the safety and efficacy of AB-3028 in subjects with metastatic castration resistant prostate cancer (mCRPC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age at time of signing informed consent form.

Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.

Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng/mL) per PCWG3 criteria.

Adequate organ functions.

Disqualifiers

Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.

Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.

Unwillingness to participate in an extended safety monitoring period.

Trial design

Design model

Single group

Treatments tested in this trial

  • AB-3028

    Biological/Vaccine

    autologous T cell therapy

Treatment groups

190 Participants
are divided into 1 treatment group
Group A: AB-3028Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of AB-3028

To assess safety and tolerability of increasing dose levels of AB-3028 in successive cohorts of subjects with metastatic CRPC to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AB-3028

Time frame
From AB-3028 infusion up to 24 months post-infusion

Secondary outcomes

Other outcomes

1

Phase 1 (Dose escalation and Backfill Cohorts): incidence of adverse events

Defined as dose-limiting toxicities based on a Bayesian optimal interval (BOIN) design

Time frame
From AB-3028 infusion up to 24 months post-infusion
2

Phase 2 (Cohort expansion): Objective response rate (ORR)

ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to RECIST v1.1

Time frame
From AB-3028 infusion up to 24 months post-infusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arsenal Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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