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SCTB35 and SCTB41 With or Without Chemotherapy in Non-Hodgkin Lymphoma

ConditionNHL - Non-Hodgkin's Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSinocelltech Ltd.

About this trial

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 80 years (inclusive) at the time of informed consent

Histologically or cytologically confirmed B cell neoplasm.

Phase 1: Relapsed or refractory disease after at least two prior systemic therapy.

Measurable or evaluable disease at enrollment.

Disqualifiers

Prior treatment with bispecific antibodies targeting both CD20 and CD3

Prior treatment with antibodies targeting both PD-1/PD-L1, PD-(L)1/VEGF(R) or PD-(L)1/TGF-β

Eligible for high dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT)

Known central nervous system (CNS) involvement by lymphoma

Trial design

Design model

Single group

Treatments tested in this trial

  • SCTB35 injection

    Drug

    SCTB35 will be subcutaneously administered at a dose as specified

  • SCTB41

    Drug

    SCTB41 will be IV administered at a dose as specified

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: SCTB35 Plus SCTB41Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: dose limited toxicity (DLT)

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

Time frame
Within 28 days of the first administration
2

Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR)

ORR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria

Time frame
Up to approximately 3 years

Secondary outcomes

1

Overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause.

Time frame
Up to approximately 3 years
2

Progression free survival (PFS)

Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.

Time frame
Up to approximately 3 years
3

Percentage of Participants Achieving CR

Percentage of participants who achieve a CR determined per Lugano criteria.

Time frame
Up to approximately 3 years
4

Duration of Response (DOR)

DOR is defined as the time from the first documented response (CR or PR) to disease progression or death, whichever occurs first.

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: