Study of PIT565 in relapsed and/or refractory B-cell malignancies

JRCT ID: jRCT2031220330

Registered date:12/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: relapsed and/or refractory B-NHL and relapsed and/or refractory B-ALL
• Date of first enrollment: 29/05/2023
• Target sample size: 12
• Countries of recruitment: Belgium,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Singapore,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Dose Escalation Part
Group A: For relapsed and/or refractory B-NHL patients, PIT565 i.v. single agent is administered. The start dose is 0.1 micro g/kg and the dose is escalated until the determination of MTD/RD. s.c.excalation part will only start after i.v. PIT565 has been determined to be safe and tolerable.
Group B: For relapsed and/or refractory B-ALL patients, PIT565 i.v. single agent is administered. The start dose is 0.1 micro g/kg and the dose is escalated until the determination of MTD/RD. s.c.excalation part will only start after i.v. PIT565 has been determined to be safe and tolerable. This part will only start once the MTD/RD of PIT565 has been determined for NHL patients.
Dose Expansion Part
Group A1: For relapsed and/or refractory large B-cell lymphoma (LBCL) (DLBCL, double/triple hit High-grade Bcell lymphoma (HGBCL), Primary mediastinal large B-cell lymphoma (PMBCL), Follicular lymphoma grade 3B (FL3B)) patients who did not receive CD19-directed CART therapy, PIT565 single agent is administered at the MTD/RD that is determined in Group A.
Group A2: For relapsed and/or refractory LBCL (DLBCL, double/triple hit HGBCL, PMBCL, FL3B) patients who received CD19-directed CAR-T therapy, PIT565 single agent is administered at the MTD/RD that is determined in Group A.
Group B1: For relapsed and/or refractory B-ALL, PIT565 single agent is administered at the MTD/RD that is determined in Group B.

Outcome(s)

Primary Outcome

Safety: Incidence and severity of Dose Limiting Toxicities (DLTs), Adverse Events (AEs) and Serious Adverse Events (SAEs), including changes in laboratory parameters, vital signs, electrocardiograms (ECGs) and assess Cytokine Release Syndrome (CRS)/
immune-mediated reactions/immune effector cell-associated neurotoxicity (ICANS).
Tolerability: Dose interruptions, reductions, and dose intensity.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 alpha CD20 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).

Exclude 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 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 than steroids as described above).

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT05397496