A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma

NCT06318884 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SCTB35-X101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma.

Conditions

Non-Hodgkin Lymphoma, B-cell

Keywords

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

• Dose-escalation part: dose limited toxicity (DLT)

  To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part

  During the first cycle (21 days)

• Dose-escalation part: incidence rate of adverse event (AE)

  To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE), adverse event with special interest (AESI)

  From first dose until 28 days after last dose of study drug or until study completion or participant withdrawal (up to 3 years)

• Dose-expansion part: objective response rate (ORR)

  ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) as determined by the investigator according to the Lugano Criteria 2014

  From first dose until up to 2 years

Secondary Outcomes (18)

• Dose-escalation part: ORR

  From first dose until up to 2 years

• Dose-escalation part: CR rate (CRR)

  From first dose until up to 2 years

• Dose-escalation part: best of overall response (BOR)

  From first dose until up to 2 years

• Dose-escalation part: duration of response (DOR)

  From first dose until up to 2 years

• Dose-escalation part: progression-free survival (PFS)

  From first dose until up to 2 years

Study Arms (1)

SCTB35

EXPERIMENTAL

SCTB35 injection is subcutaneously given every week for the first 4 cycles, and thereafter every 3 weeks. Cycles will be repeated every 3 weeks until disease progression, study discontinuation, or death, whichever occurs first.

Drug: SCTB35 injection

Interventions

SCTB35 injection DRUG

SCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and another appropriate dose of SCTB35 will be applied for the dose-expansion cohorts.

Also known as: none other names

SCTB35

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the study only if all the following conditions are met:
• Age ≥ 18 years
• Histologically or cytologically confirmed CD20+ mature B-cell neoplasm
• For dose-escalation phase:
• De novo or transformed diffuse large B-cell lymphoma (DLBCL)
• High-grade B-cell lymphoma (HGBCL)
• Primary mediastinal large B-cell lymphoma (PMBCL)
• Follicular lymphoma (FL)
• Mantle cell lymphoma
• Small lymphocytic lymphoma (SLL)
• Marginal zone lymphoma (MZL) (nodal, extranodal or mucosa associated)
• For dose expansion phase:
• FL cohort: histologic confirmed FL grade 1, 2, or 3a at initial diagnosis without clinical or pathological evidence of transformation
• LBCL cohort: including histologic confirmed DLBCL, not otherwise specified (NOS), Epstein-Barr virus+ DLBCL, transformed DLBCL from indolent subtypes, HGBCL, NOS, double/triple-hit HGBCL, FL grade 3b, and PMBCL
• For dose-escalation phase:

You may not qualify if:

• A patient who conforms to any of the following criteria should be excluded from the study:
• Any prior therapy with an bispecific antibody of the same class
• Eligible for high dose chemotherapy with hematopoietic stem cell transplantation (HSCT)
• Known central nervous system (CNS) involvement by lymphoma
• Cervical carcinoma of Stage Ib or less
• Non-invasive basal cell or squamous cell skin carcinoma
• Non-invasive, superficial bladder cancer
• Prostate cancer with a current prostate-specific antigen (PSA) level \<0.1 ng/mL
• Any curable cancer with a complete response (CR) of \>2 years duration
• Known clinically significant cardiac disease, including:
• Onset of unstable angina pectoris or acute myocardial infarction within 6 months prior to signing Informed Consent Form (ICF)
• Congestive heart failure prior to signing ICF (meets the criteria of New York Heart Association Classification III or IV)
• Clinically significant arrhythmia prior to signing ICF
• History of interstitial lung disease or uncontrolled lung diseases, or evidence of dyspnea at rest or pulse oximetry \< 93% while breathing room air.
• Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy (including \>20mg/day prednisolone \[or equivalent\], but low-dose prednisolone is allowed). The well controlled autoimmune disease can be enrolled at investigator's discretion, including:

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuqin Song, M.D.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junfan Ma, Ph.D

CONTACT

86-010-58628288; junfan_ma@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CN (3)