Health TrialsbyHealthPanel

A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma

ConditionRelapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorExcyte Biopharma Ltd

About this trial

This study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.

Diagnosis of multiple myeloma according to the IMWG criteria.

Receipt of at least two prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.

Serum M-protein ≥0.5 g/dL;

Disqualifiers

Plasma cell leukemia (>2.0×10^9/L plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary light-chain amyloidosis.

Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer;

Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 2 weeks;

Chemotherapy within 2 weeks;

Trial design

Design model

Sequential

Treatments tested in this trial

  • YKST02

    Drug

    BCMA-CD3 bispecific antibody

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: YKST02Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Dose-limiting Toxicities (DLT)

The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.

Time frame
21 days after the first dose
2

Incidence of Adverse Events (AEs)

An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.

Time frame
up to 42 weeks
3

Incidence of Serious Adverse Events (SAEs)

A SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the investigational drug, and congenital abnormalities or birth defects.

Time frame
up to 42 weeks
4

Overall Response Rate (ORR)

Measured by IMWG criteria, only applicable in dose expansion phase

Time frame
From the date of dosing until the date of first documented progression

Secondary outcomes

1

Area under the Concentration-time Curve (AUC) after Administration

AUC of YKST02

Time frame
up to 42 weeks
2

Maximum Serum Concentration (Cmax) of YKST02

Cmax is defined as the maximum observed serum concentration of YKST02

Time frame
up to 42 weeks
3

Time to Cmax of YKST02 (Tmax)

Time to maximum serum concentration (Tmax) of YKST02

Time frame
up to 42 weeks
4

Terminal Half-life (T1/2) of YKST02

Terminal Half-life (T1/2) of YKST02

Time frame
up to 42 weeks

Other outcomes

Sponsors and contacts

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

Excyte Biopharma Ltd

Lead sponsor

Source ClinicalTrials.gov
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