Health TrialsbyHealthPanel

NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma

ConditionNon Hodgkin Lymphoma (NHL)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-80
SponsorNOBO Medicine

About this trial

This trial is an open-label, multicenter, monotherapy, dose-escalation, phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of NB02 (posseltinib) in patients with relapsed/refractory NHL including FL, MCL and MZL

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 19 to 80 years.

Patients must voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures.

Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma.

relapsed/refractory Patients who have received more than two prior lines of therapy.

Disqualifiers

Previous treatment with NB02 (poseltinib).

Patients who have experienced progression on BTKi mono or BTKi containing regimen (However, patients who discontinued treatment due to adverse-effect-related intolerance or for economic or social reasons remain eligible for enrollment).

Unable to take oral medication.

Inability to comply with study and follow-up procedures.

Trial design

Design model

Single group

Treatments tested in this trial

  • NB02 (Poseltinib)

    Drug

    Dose Level 1, Dose Level 2, Dose Level 3

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: NB02 (Poseltinib)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MTD(maximum tolerated dose) or OBD(optimal biological dose)

MTD(maximum tolerated dose) or OBD(optimal biological dose)

Time frame
Approximately 48 Months
2

AEs

AEs

Time frame
Approximately 48 Months

Secondary outcomes

1

Pharmacokinetic (PK) Ctrough

Pharmacokinetic (PK) parameters from plasma samples

Time frame
Day 147
2

Pharmacokinetic (PK) t1/2

Pharmacokinetic (PK) parameters from plasma samples

Time frame
Day 147
3

Pharmacokinetic (PK) CL/F

Pharmacokinetic (PK) parameters from plasma samples

Time frame
Day 147
4

Pharmacokinetic (PK) Vz/F

Pharmacokinetic (PK) parameters from plasma samples

Time frame
Day 147

Other outcomes

Sponsors and contacts

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

NOBO Medicine

Lead sponsor

Source ClinicalTrials.gov
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