B-cell Non-Hodgkin Lymphoma (B-NHL)Phase 1NCT05397496
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
A Phase 1 study testing PIT565 in people with B-cell Non-Hodgkin Lymphoma (B-NHL) and B-cell Acute Lymphoblastic Leukemia (B-ALL), run by Novartis Pharmaceuticals at 18 sites in 9 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma (B-NHL), B-cell Acute Lymphoblastic Leukemia (B-ALL)
- What is being tested?
- PIT565
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 18 sitesin 9 countries
- Study dates
- 3 Oct 2022to 4 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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 metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the 2 weeks prior to the start of study treatment
- Active, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur
- Patients receiving systemic treatment with any immunosuppressive medication
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
18 sites in 9 countries.
18 sites in 9 countries
United States5 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
The University of Kansas Clinical Research Ctr
Fairway, Kansas, 66205
University Of Miami
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
Oregon Health Sciences University
Portland, Oregon, 97239
China3 sites
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Tianjin, 300020
France2 sites
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Marseille, 13273
Singapore2 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 169608
Spain2 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Barcelona, 08036
About this study
Official title: A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies
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).
Read the detailed description
This is an open-label, multicenter, phase I study of PIT565 in patients with R/R B-NHL and R/R B-ALL.
The study comprises a dose escalation part of PIT565 in two independent groups (group A: R/R B-NHL and B: R/R B-ALL) and a dose expansion part in three independent groups (R/R large B-cell lymphoma (LBCL) randomized in 1:1 ratio to two RDs (A1 and A2), and R/R B-ALL (B1)).
During the dose escalation, the safety (including the dose-dose limiting toxicity (DLT) relationship) and tolerability of PIT565 will be assessed, and schedule(s), route(s) of administration and dose(s) will be identified for use in the expansion part based on the review of these data. The RD will also be guided by the available information on pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity. The dose escalation will be guided by an adaptive Bayesian logistic regression model (BLRM) following the Escalation with Overdose Control (EWOC) principle.
Different schedules and routes of administrations will be explored in the dose escalation groups.
The dose expansion will further explore the MTD(s) and/or RD(s) and the selected schedule(s) and route of administration(s) in the three patients' groups.
- Being tested
- PIT565
- Keywords
- Phase I, Trispecific antibody, Non-Hodgkin lymphoma, Acute Lymphoblastic Leukemia, PIT565
- Medical subject headings
- Lymphoma, B-Cell, Burkitt Lymphoma, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIT565Biological
Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection
| Study group | Role | What they receive |
|---|---|---|
| PIT565 Group A (dose escalation part) | Experimental | 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 Receives: Biological: PIT565 |
| PIT565 Group B (dose escalation part) | Experimental | PIT565 in adult R/R ALL patients. Receives: Biological: PIT565 |
| PIT565 Group A1 (dose expansion part) | Experimental | PIT565 Recommended dose 1 (RD1) 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. Receives: Biological: PIT565 |
| PIT565 Group A2 (dose expansion part) | Experimental | PIT565 RD2 in adult R/R LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients. Receives: Biological: PIT565 |
| PIT565 Group B1 (dose expansion part) | Experimental | PIT565 in adult R/R ALL patients. Receives: Biological: PIT565 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Dose Limiting Toxicities (DLTs)
Assessment of safety of study drug. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of CTCAE grade 3 or higher that occurs within the DLT evaluation period (28 days or 35 days depending on the schedule) and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with exceptions provided in the clinical protocol.
Measured: 28 days or 35 days, depending on the dosing schedule
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessment of safety of study drug.
Measured: 21 months
Frequency of dose interruptions
Assessment of tolerability of study drug
Measured: 21 months
Frequency of dose reductions
Assessment of tolerability of study drug
Measured: 21 months
Dose intensities
Assessment of tolerability of study drug Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.
Measured: 21 months
Secondary outcomes (12)
Overall Response Rate (ORR)
Evaluation of anti-tumor activity of PIT565 for Non-Hodgkin Lymphoma will be based on the Lugano Response Criteria Classification and anti-tumor activity of PIT565 for Acute Lymphoblastic Leukemia will be based on National Comprehensive Cancer Network (NCCN) 2018 v1 guidelines. Local investigator assessment will be used for analysis of efficacy endpoints.
Measured: 21 months
Complete Response (CR) rate
Evaluation of anti-tumor activity of PIT565 for Non-Hodgkin Lymphoma will be based on the Lugano Response Criteria Classification and anti-tumor activity of PIT565 for Acute Lymphoblastic Leukemia will be based on National Comprehensive Cancer Network (NCCN) 2018 v1 guidelines. Local investigator assessment will be used for analysis of efficacy endpoints.
Measured: 21 months
Best Overall Response (BOR)
Evaluation of anti-tumor activity of PIT565 for Non-Hodgkin Lymphoma will be based on the Lugano Response Criteria Classification and anti-tumor activity of PIT565 for Acute Lymphoblastic Leukemia will be based on National Comprehensive Cancer Network (NCCN) 2018 v1 guidelines. Local investigator assessment will be used for analysis of efficacy endpoints.
Measured: 21 months
Duration Of Response (DOR)
Evaluation of anti-tumor activity of PIT565 for Non-Hodgkin Lymphoma will be based on the Lugano Response Criteria Classification and anti-tumor activity of PIT565 for Acute Lymphoblastic Leukemia will be based on National Comprehensive Cancer Network (NCCN) 2018 v1 guidelines. Local investigator assessment will be used for analysis of efficacy endpoints.
Measured: 21 months
Overall Survival (OS)
Evaluation of anti-tumor activity of PIT565 for Non-Hodgkin Lymphoma will be based on the Lugano Response Criteria Classification and anti-tumor activity of PIT565 for Acute Lymphoblastic Leukemia will be based on National Comprehensive Cancer Network (NCCN) 2018 v1 guidelines. Local investigator assessment will be used for analysis of efficacy endpoints.
Measured: 33 months
Progression Free Survival (PFS)
Evaluation of anti-tumor activity of PIT565 for Non-Hodgkin Lymphoma will be based on the Lugano Response Criteria Classification Local investigator assessment will be used for analysis of efficacy endpoints.
Measured: 21 months
Event-free survival (EFS)
Evaluation of anti-tumor activity of PIT565 for Acute Lymphoblastic Leukemia will be based on National Comprehensive Cancer Network (NCCN) 2018 v1 guidelines. Local investigator assessment will be used for analysis of efficacy endpoints.
Measured: 21 months
Maximum concentration of PIT565 (Cmax)
Pharmacokinetics (PK) parameters will be determined using non-compartmental method(s)
Measured: 21 months
Area Under the Curve of PIT565 (AUC)
Pharmacokinetics (PK) parameters will be determined using non-compartmental method(s)
Measured: 21 months
Trough concentration of PIT565 (C trough)
Pharmacokinetics (PK) parameters will be determined using non-compartmental method(s)
Measured: 21 months
Prevalence of Anti-drug antibodies (ADA) at baseline
Assessment of anti-PIT565 antibodies in serum.
Measured: Baseline
Incidence of Anti-drug antibodies (ADA) on treatment
Assessment of anti-PIT565 antibodies in serum.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start3 Oct 2022
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin Lymphoma (B-NHL)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397496
- Sponsor's protocol ID
- CPIT565A12101
- Other IDs
- 2022-000367-45
- Status last verified
- Jul 2026
- First submitted
- 25 May 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies
- ClinicalTrials.gov ID
- NCT05397496
- Acronym / sponsor ID
- CPIT565A12101
- Keywords
- Phase I, Trispecific antibody, Non-Hodgkin lymphoma, Acute Lymphoblastic Leukemia, PIT565
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is an open-label, multicenter, phase I study of PIT565 in patients with R/R B-NHL and R/R B-ALL.
The study comprises a dose escalation part of PIT565 in two independent groups (group A: R/R B-NHL and B: R/R B-ALL) and a dose expansion part in three independent groups (R/R large B-cell lymphoma (LBCL) randomized in 1:1 ratio to two RDs (A1 and A2), and R/R B-ALL (B1)).
During the dose escalation, the safety (including the dose-dose limiting toxicity (DLT) relationship) and tolerability of PIT565 will be assessed, and schedule(s), route(s) of administration and dose(s) will be identified for use in the expansion part based on the review of these data. The RD will also be guided by the available information on pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity. The dose escalation will be guided by an adaptive Bayesian logistic regression model (BLRM) following the Escalation with Overdose Control (EWOC) principle.
Different schedules and routes of administrations will be explored in the dose escalation groups.
The dose expansion will further explore the MTD(s) and/or RD(s) and the selected schedule(s) and route of administration(s) in the three patients' groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PIT565 Group A (dose escalation part) | Experimental | Biological: PIT565PIT565 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 |
| PIT565 Group B (dose escalation part) | Experimental | Biological: PIT565PIT565 in adult R/R ALL patients. |
| PIT565 Group A1 (dose expansion part) | Experimental | Biological: PIT565PIT565 Recommended dose 1 (RD1) 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. |
| PIT565 Group A2 (dose expansion part) | Experimental | Biological: PIT565PIT565 RD2 in adult R/R LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients. |
| PIT565 Group B1 (dose expansion part) | Experimental | Biological: PIT565PIT565 in adult R/R ALL patients. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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 metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the 2 weeks prior to the start of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIT565Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection | Biological | PIT565 Group A (dose escalation part), PIT565 Group A1 (dose expansion part), PIT565 Group A2 (dose expansion part), PIT565 Group B (dose escalation part), PIT565 Group B1 (dose expansion part) |
Primary outcome
Incidence and severity of Dose Limiting Toxicities (DLTs)
Time frame: 28 days or 35 days, depending on the dosing schedule
Assessment of safety of study drug. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of CTCAE grade 3 or higher that occurs within the DLT evaluation period (28 days or 35 days depending on the schedule) and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with exceptions provided in the clinical protocol.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 21 months
Assessment of safety of study drug.
Frequency of dose interruptions
Time frame: 21 months
Assessment of tolerability of study drug
Frequency of dose reductions
Time frame: 21 months
Assessment of tolerability of study drug
Dose intensities
Time frame: 21 months
Assessment of tolerability of study drug Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.
12 secondary outcomes
Overall Response Rate (ORR)
Time frame: 21 months
Complete Response (CR) rate
Time frame: 21 months
Best Overall Response (BOR)
Time frame: 21 months
Duration Of Response (DOR)
Time frame: 21 months
Overall Survival (OS)
Time frame: 33 months
Progression Free Survival (PFS)
Time frame: 21 months
Event-free survival (EFS)
Time frame: 21 months
Maximum concentration of PIT565 (Cmax)
Time frame: 21 months
Area Under the Curve of PIT565 (AUC)
Time frame: 21 months
Trough concentration of PIT565 (C trough)
Time frame: 21 months
Prevalence of Anti-drug antibodies (ADA) at baseline
Time frame: Baseline
Incidence of Anti-drug antibodies (ADA) on treatment
Time frame: 21 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for B-cell Non-Hodgkin Lymphoma (B-NHL)
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Active, not recruitingPhase 1
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Relapsed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PIT565 in people with B-cell Non-Hodgkin Lymphoma (B-NHL) and B-cell Acute Lymphoblastic Leukemia (B-ALL), run by Novartis Pharmaceuticals at 18 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, China, France, Singapore, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Dose Limiting Toxicities (DLTs) (time frame: 28 days or 35 days, depending on the dosing schedule). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.