Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple Myeloma

Keywords

multiple myelomaCID-103anti-CD38 antibody

Outcome Measures

Primary Outcomes (1)

Adverse events
CTCAE v5 coded using the current Medical Dictionary for Regulatory Activities (MedDRA) version
approximately 18 months after study start

Secondary Outcomes (12)

Recommended Phase 2 dose
approximately 18 months after study start
Optimal pre- and post-medication regimens
approximately 18 months after study start
Target engagement assays and ex vivo testing
approximately 18 months after study start
PK - AUC of CID-103
approximately 18 months and 3 years after study start
PK - Cmax of CID-103
approximately 18 months and 3 years after study start
+7 more secondary outcomes

Other Outcomes (1)

Target binding of CID-103
approximately 3 years after study start

Study Arms (3)

Dose escalation cohort

EXPERIMENTAL

Monotherapy CID-103. Priming dose will be given for first dose. Dose and duration of infusion dependent on dose cohort and tolerability.

Drug: CID-103

Dose expansion cohort - pretreated

EXPERIMENTAL

CID-103 monotherapy at the recommended phase 2 dose

Drug: CID-103

Dose expansion cohort - Naïve

EXPERIMENTAL

CID-103 monotherapy at the recommended phase 2 dose

Interventions

CID-103Drug

anti-CD38 antibody

Dose escalation cohortDose expansion cohort - NaïveDose expansion cohort - pretreated

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able and willing to sign the ICF and comply with the protocol
Male or female ≥ 18 years of age

Sponsors & Collaborators

CASI pharmaceuticals, Inc.
Industrylead

Study Sites (4)

CHU de Nantes - Hôpital Hôtel-Dieu

Nantes, France

CHU Rennes - Pontchaillou

Rennes, France

Gustave Roussy Cancer Center

Villejuif, France

Sarah Cannon

London, United Kingdom

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

Alexander Zukiwski, MD
Casi Pharmaceuticals
STUDY DIRECTOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 17, 2021

Study Start

March 22, 2021

Actual (reported)

CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Other Outcomes (1)

Study Arms (3)

Dose escalation cohort

Dose expansion cohort - pretreated

Dose expansion cohort - Naïve

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Other Outcomes (1)

Study Arms (3)

Dose escalation cohort

Dose expansion cohort - pretreated

Dose expansion cohort - Naïve

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations