Prostate Cancer Metastatic
Conditions
Keywords
PSMA, mCRPC, Cell therapy, chimeric antigen receptor (CAR) t-cell therapy
Brief summary
This is a Phase 1/2 multicenter, open-label, dose finding and dose expansion study of ADI-212 in participants with metastatic castration-resistant prostate cancer (mCRPC)
Interventions
DRUGADI-212
Allogeneic cell therapy
DRUGFludarabine
Chemotherapy for Lymphodepletion
DRUGCyclophosphamide
Chemotherapy for Lymphodepletion
Sponsors
Adicet Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3+3 Dose Escalation Design
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic and/or cytologic confirmation of adenocarcinoma of the prostate * Documented evidence of metastatic disease. * Target lesions must be PSMA-avid by PET/CT, based on local determination. * Must have castration testosterone level (\< 50 ng/dL) and must remain on androgen deprivation therapy (ADT) to maintain this level. * Progressive mCRPC based on at least one of the following: 1. PSA progression defined as two increases in PSA measured at least one week apart 2. Soft-tissue progression defined per PCWG3 3. Bone disease progression defined per PCWG3 * Evaluable target lesions, per PCWG3 * ECOG of 0 or 1 * Prior therapy : 1. Participants must have progressed after at least two prior courses of systemic ADT. 2. Participants may have had no more than one course of prior taxane therapy. 3. Prio PSMA-targeted radioligand therapy (e.g., Pluvicto) is permitted. 4. Prior PARP inhibitor therapy is permitted. 5. Must have prior therapy washout, including investigational agents, of at least three weeks for prior systemic therapies other than androgen deprivation therapies, or five half-lives if the duration is shorter than three weeks. * Adequate BP, hematological, and organ function
Exclusion criteria
* Prior radiation therapy within 21 days prior to start of study treatment * Prior positive superscan results \[i.e.: an imaging appearance on a Tc-99m diphosphonate bone scan\] * Current or history of any of the following conditions or treatments: 1. Presence of known central nervous system (CNS) metastases 2. History of clinically significant infection 3. Active malignancy within the past 24 months 4. Any other condition requiring treatment with a prohibited medication, as specified in the protocol 5. Prior treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy 6. Prior PSMA-targeted therapies other than a single course of a PSMA-targeted radioligand therapy * Prior CAR-T therapy * Clinically significant cardiovascular disease * Prior solid organ transplant * Unwilling to participate in an extended safety monitoring period * Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of Subjects with Dose Limiting Toxicity within each dose level | Day 42 | The primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed Dose (MAD) and Recommended Phase 2 Dose (RP2D) |
| Proportion of treatment emergent and treatment related Adverse Events | 2 years | This primary endpoint will be used to determine Overall Response Rate (ORR) per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 per local assessment and Radiographic progression-free survival (rPFS) |
Countries
United States
Contacts
CONTACTAdicet Medical Director
Outcome results
None listed