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

NCT04758767 | Completed Phase 1 DMC

• 2 other identifiers: CASI-CID-103-1012019-004006-10
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 4

Brief Summary

Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; CID-103; anti-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

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

Drug: CID-103

Interventions

CID-103 DRUG

anti-CD38 antibody

Dose escalation cohort; Dose expansion cohort - Naïve; Dose expansion cohort - pretreated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Agrees to bone marrow aspirates
• Must have pathologically confirmed multiple myeloma
• Has relapsed or refractory myeloma
• At least 2 prior systemic anti-cancer therapies for relapsed or refractory multiple myeloma, including an immunomodulatory agent and a proteasome inhibitor
• Meets all IMWG 2014 criteria at diagnosis or at time of current relapse
• Measurable disease
• If female, must be of non-childbearing potential, or have a negative pregnancy test at screening and use highly adequate contraception throughout study until 90 days after last dose
• If male with partner of childbearing potential, be vasectomized or female partner must use highly adequate contraception throughout study until 180 days after last dose
• All previous therapy-related adverse events should have resolved, prior to Day 1, to Grade 1 or baseline value with the exception of alopecia (includes effects of radiotherapy)
• Adequate organ function as indicated by neutrophils, platelets, hemoglobin, eGFR, serum total and direct bilirubin, AST, ALT, INR, aPTT

You may not qualify if:

• Received small molecule or tyrosine kinase inhibitor within two weeks or five half-lives (whichever is longer) prior to the first dose of study drug; chemotherapy or biological cell-based cancer therapy within four weeks prior to the first dose of study drug; nitrosourea or radioisotope within six weeks prior to first dose of study drug, non-recovery to the CTCAE v5 Grade 1 or better from the adverse events due to cancer therapeutics administered more than four weeks earlier.
• Received an anti-CD38 therapy within four months from first dose of study drug
• Inability to perform study baseline RBC type and cross-match, phenotype, genotype (if applicable) or lack of available baseline data on RBC phenotype or genotype (if applicable)
• Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of study drug or five half-lives, if known, whichever is shorter
• Currently receiving systemic steroids unless equivalent to 10 mg/day of prednisone or less for adrenal replacement only. At least two weeks since last dose of steroid therapy intended for the treatment of myeloma and the first dose of study drug.
• Non-secretory myeloma unless measurable plasmacytoma
• Known hypersensitivity to CID-103 excipients or prior severe hypersensitivity to a monoclonal antibody
• Baseline interval between Q and T wave on electrocardiogram \> 480 msec using Fridericia's formula (QTcF)
• Requires renal dialysis
• Sensory or motor neuropathy ≥ Grade 3
• Known/clinically significant amyloidosis
• Known active central nervous system disease or leptomeningeal plasmacytoma.
• Presence of any other active malignancy requiring systemic therapy other than the disease under study
• Active infection requiring systemic therapy
• Active infection with human immunodeficiency virus and CD4+ T-cell count \< 350/μL

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (4)

CHU de Nantes - Hôpital Hôtel-Dieu

Nantes, France

Location

CHU Rennes - Pontchaillou

Rennes, France

Location

Gustave Roussy Cancer Center

Villejuif, France

Location

Sarah Cannon

London, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alexander Zukiwski, MD

  CASI Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: Single arm dose escalation, followed by dose expansion arm (2 cohorts)

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 17, 2021
• Study Start: March 22, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); GB (1)