Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma

Keymed Biosciences

Status and phase

Unknown

Phase 1

Conditions

Multiple Myeloma

Lymphoma

Treatments

Drug: CM313-Dose escalation

Drug: Lenalidomide

Drug: CM313

Drug: Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT04818372

CM313MM001

Details and patient eligibility

About

This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CM313.

The dose escalation part will determine the MTD of CM313 in subjects with relapsed and/or refractory multiple myeloma (RRMM) or lymphoma based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design).

The dose expansion part includes two cohorts. Cohort 1 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Dexamethasone in subjects with RRMM. Cohort 2 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Rd regimen (Lenalidomide/Dexamethasone) in subjects with RRMM or newly diagnosed MM (NDMM).

Enrollment

87 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Dose escalation: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies and subjects with recurrent and refractory lymphoma.
Dose expansion_cohort 1: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies.
Dose expansion_cohort 2: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies, or subjects with NDMM.
For MM: Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
For MM: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
Eastern Cooperative Oncology Group (ECOG) performance status score <＝2.
Women of childbearing potential and male subjects must agree to remain abstinent or use contraceptive methods as defined by the protocol.
Side effects of any prior therapy or procedures for any medical condition has recovered to NCI-CTCAE v.5.0 Grade ≤ 1.

Key Exclusion Criteria:

Previous treatment with any anti-CD38 therapy.
Subjects with concurrent plasma cell leukemia.
Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication).
Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
Received an allogenic stem cell transplant or an autologous stem cell transplant within 3 months before first dose of study drug.
Central nervous system (CNS) involvement.
The forced expiratory volume in one second (FEV1)<60%.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

87 participants in 3 patient groups

Dose escalation

Experimental group

Description:

Subjects enrolled in this arm will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals. Dose escalation will be carried out according to a modified 3+3 dose-escalation design. Accelerated dose titration design will be used for the first 4 dose levels (0.006mg/kg, 0.06mg/kg, 0.3mg/kg and 1.0mg/kg) and then traditional 3+3 dose escalation design will be used for the following levels (2.0mg/kg, 4.0mg/kg, 8.0mg/kg, 16mg/kg and 24mg/kg).

Treatment:

Drug: CM313-Dose escalation

Dose expansion _Cohort 1

Experimental group

Description:

This cohort will comprise subjects with RRMM. Subjects will receive the CM313 in combination with dexamethasone.

Treatment:

Drug: Dexamethasone

Drug: CM313

Dose expansion _Cohort 2

Experimental group

Description: