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CAR T-cell Therapy

PIT565 for B-Cell Lymphoma or Leukemia

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Male or female patients ≥18 years of age at the date of signing the informed consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 months
Awards & highlights

Study Summary

This trial tests a new drug to treat B-cell lymphoma and leukemia, aiming to find safe doses and how to use it.

Who is the study for?
Adults over 18 with B-cell Non-Hodgkin lymphoma or acute lymphoblastic leukemia that's come back or didn't respond to treatment, including a CD20 monoclonal antibody regimen. They must have measurable disease and be in relatively good health (ECOG ≤2). Not for those with severe allergies to study ingredients, ongoing infections, other cancers within the last 2 years (with some exceptions), CNS involvement by cancer, active autoimmune diseases, or on immunosuppressants.Check my eligibility
What is being tested?
The trial is testing PIT565's safety and finding the highest dose patients can take without serious side effects in relapsed/refractory B-cell malignancies. It's an early-phase study where everyone gets PIT565 to determine how well it works and what doses are safe.See study design
What are the potential side effects?
While specific side effects of PIT565 aren't listed here as it’s a new drug under investigation, common ones may include reactions at the infusion site, fatigue, fever-like symptoms due to immune activation, potential organ inflammation similar to other immunotherapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years or older and have signed the consent form.
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My leukemia has returned or is not responding to treatment, and tests show more than 5% cancer cells in my bone marrow.
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My B-NHL has not responded to at least two treatments, including one with an αCD20 drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose intensities
Frequency of dose interruptions
Frequency of dose reductions
+2 more
Secondary outcome measures
Area Under the Curve of PIT565 (AUC)
Best Overall Response (BOR)
Complete Response (CR) rate
+9 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: PIT565 Group B1 (dose expansion part)Experimental Treatment1 Intervention
PIT565 in adult R/R ALL patients
Group II: PIT565 Group B (dose escalation part)Experimental Treatment1 Intervention
PIT565 in adult R/R ALL patients
Group III: PIT565 Group A2 (dose expansion part)Experimental Treatment1 Intervention
PIT565 in adult R/R LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients who received CD19-directed CAR-T therapy
Group IV: PIT565 Group A1 (dose expansion part)Experimental Treatment1 Intervention
PIT565 in adult R/R large B-cell lymphoma (LBCL) (DLBCL, double/triple hit High-grade B-cell lymphoma (HGBCL), Primary mediastinal large B-cell lymphoma (PMBCL), Follicular lymphoma grade 3B (FL3B)) patients who did not receive CD19-directed CAR-T therapy
Group V: PIT565 Group A (dose escalation part)Experimental Treatment1 Intervention
PIT565 in adult NHL patients for whom two or more lines of chemotherapy have failed and either having progressed (or relapsed) after autologous hematopoietic stem cell transplantation (HSCT), or being ineligible for or not consenting to the procedure

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,198,169 Total Patients Enrolled

Media Library

PIT565 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05397496 — Phase 1
PIT565 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397496 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: PIT565 Group A1 (dose expansion part), PIT565 Group B1 (dose expansion part), PIT565 Group A (dose escalation part), PIT565 Group A2 (dose expansion part), PIT565 Group B (dose escalation part)
Non-Hodgkin's Lymphoma Clinical Trial 2023: PIT565 Highlights & Side Effects. Trial Name: NCT05397496 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with participation in the dose escalation part of PIT565 Group A?

"PIT565 Group A (dosing escalation section) was assigned a safety rating of 1, since it is in the first phase and has limited evidence to support its efficacy or security."

Answered by AI

How many participants is the medical study recruiting?

"Agreement, the details documented on clinicaltrials.gov demonstrate that this experiment is presently enlisting patients with its original post date of October 3rd 2022 and most recent update occurring May 23rd 2023. A total of 140 participants from 8 different institutions are required for inclusion in the trial."

Answered by AI

Are there still vacancies available for individuals to join this experiment?

"According to the records on clinicaltrials.gov, this medical trial is recruiting participants. This study was initially posted in October of 2022 and most recently modified in May 2023."

Answered by AI

Has this trial been implemented in various parts of Canada?

"This clinical trial is accepting participants at 8 different medical sites, including the cities of Gent, Singapore and Marseille. To minimize time away from home if you join this study it would be prudent to select a location nearby."

Answered by AI

What aims is this trial attempting to fulfill?

"According to Novartis Pharmaceuticals, this clinical trial will be measuring the Frequency of dose interruptions over a 21-month period. Secondary outcomes such as Best Overall Response (BOR), Progression Free Survival (PFS) and Overall Response Rate (ORR) will also be assessed through Lugano Response Criteria Classification Local investigator assessment and National Comprehensive Cancer Network (NCCN) 2018 v1 guidelines respectively."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
2022. "Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05397496.
~92 spots leftby Jun 2027
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