Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies (NCT05397496) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
United States, Belgium, China61 participantsStarted 2022-10-03
Plain-language summary
This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent must be obtained prior to participation in the study.
* Male or female patients ≥18 years of age at the date of signing the informed consent form
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
NHL patient population
* Refractory or relapsed B-NHL
* Must have relapsed after or failed to respond to at least two prior treatment therapies including an αCD20 monoclonal antibody containing chemotherapy combination regimen
* Must have at least one bi-dimensionally measurable nodal lesion or one bi-dimensionally measurable extranodal lesion, as measured on positron emission tomography-computed tomography (PET/CT) scan
ALL patient population
* Refractory or relapsed CD19-positive B-ALL
* Morphologic disease in the bone marrow (≥ 5% blasts)
Exclusion Criteria:
* History of severe hypersensitivity to any ingredient of the study treatment or its excipients
* Contraindication to tocilizumab
* History of ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
* Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type
* Active central nervous system (CNS) involvement by malignancy or presence of symptomatic CNS m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial of PIT565 — a drug that hasn't been widely tested in people yet — what is currently known about its safety profile, and how does that uncertainty factor into whether this might be right for my situation?
2The trial is measuring things like dose-limiting toxicities and how often doses need to be reduced or interrupted, which suggests the researchers are still figuring out the safest dose — can you explain what that means for the level of risk I'd be taking on compared to standard treatment options for my relapsed or refractory B-cell malignancy?
3The study is listed as 'active not recruiting,' which means they're no longer enrolling new patients — does that mean this specific trial is no longer an option for me, and are there similar or follow-on studies I should be looking into instead?
4Given that the primary focus of this trial is on safety and tolerability rather than measuring whether the treatment is working, what would my care team be watching for during treatment to decide whether to continue, adjust, or stop my participation?
5For someone with relapsed or refractory B-NHL or B-ALL like mine, would my doctor recommend exhausting other established salvage therapies or CAR-T options before considering an early-phase experimental trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of Dose Limiting Toxicities (DLTs)
Timeframe: 28 days or 35 days, depending on the dosing schedule
2
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)