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Trial record 1 of 1 for:    CID103
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CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04758767
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
CASI Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CID-103 Phase 1

Detailed Description:

Dose escalation/infusion duration phase:

During the CID-103 dose escalation/infusion duration phase, only patients diagnosed with multiple myeloma who have relapsed or are refractory to at least two prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody will be enrolled. Patients will receive monotherapy CID-103. Dose escalation decisions will be based on dose-limiting toxicities; infusion duration decisions will be based on infusion-related reactions. The dose taken forward into the expansion phase will be the RP2D determined in the dose escalation phase.

Expansion phase:

The expansion phase consists of two specific cohorts of patients with relapsed/refractory multiple myeloma: 1) Pretreated cohort having received previous treatment with an anti-CD38 antibody and 2) Naïve cohort in patients for whom an anti-CD38 antibody is unavailable. Eight patients will be enrolled into each cohort, and if one or more responses is observed, that cohort will be expanded to a total of 14 patients to further assess efficacy. Patients must have had at least two prior systemic therapies (mono or combo), including a proteasome inhibitor and an immunomodulatory agent. Patients will be treated until disease progression or unacceptable toxicities.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single arm dose escalation, followed by dose expansion arm (2 cohorts)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation and Expansion Study of CID-103, an Anti-CD38 Antibody, in Patients With Previously Treated Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Dose escalation cohort
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
anti-CD38 antibody

Experimental: Dose expansion cohort - pretreated
CID-103 monotherapy at the recommended phase 2 dose
Drug: CID-103
anti-CD38 antibody

Experimental: Dose expansion cohort - Naïve
CID-103 monotherapy at the recommended phase 2 dose
Drug: CID-103
anti-CD38 antibody




Primary Outcome Measures :
  1. Adverse events [ Time Frame: approximately 18 months after study start ]
    CTCAE v5 coded using the current Medical Dictionary for Regulatory Activities (MedDRA) version


Secondary Outcome Measures :
  1. Recommended Phase 2 dose [ Time Frame: approximately 18 months after study start ]
    Based primarily on dose-limiting toxicities

  2. Optimal pre- and post-medication regimens [ Time Frame: approximately 18 months after study start ]
    Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities will be compared before and after the changes in pre/post medications are made, with specific focus on IRRs and their symptoms

  3. Target engagement assays and ex vivo testing [ Time Frame: approximately 18 months after study start ]
    Extent of RBC binding and cross-match confounding

  4. PK - AUC of CID-103 [ Time Frame: approximately 18 months and 3 years after study start ]
    AUC of CID-103 in serum

  5. PK - Cmax of CID-103 [ Time Frame: approximately 18 months and 3 years after study start ]
    Cmax of CID-103 in serum

  6. PK - t1/2 of CID-103 [ Time Frame: approximately 18 months and 3 years after study start ]
    half-life of CID-103 in serum

  7. PK - Vd of CID-103 [ Time Frame: approximately 18 months and 3 years after study start ]
    volume of distribution of CID-103 in serum

  8. PK - accumulation of CID-103 [ Time Frame: approximately 18 months and 3 years after study start ]
    accumulation of CID-103 in serum

  9. Objective response rate [ Time Frame: approximately 3 years after study start ]
    Based on IMWG

  10. Duration of response [ Time Frame: approximately 3 years after study start ]
    Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG

  11. Progression-free survival [ Time Frame: approximately 3 years after study start ]
    Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG

  12. Overall survival [ Time Frame: approximately 3 years after study start ]
    Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG


Other Outcome Measures:
  1. Target binding of CID-103 [ Time Frame: approximately 3 years after study start ]
    Target binding on different circulating blood cell populations and the potential PD markers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able and willing to sign the ICF and comply with the protocol
  2. Male or female ≥ 18 years of age
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. Agrees to bone marrow aspirates
  5. Must have pathologically confirmed multiple myeloma
  6. Has relapsed or refractory myeloma
  7. At least 2 prior systemic anti-cancer therapies for relapsed or refractory multiple myeloma, including an immunomodulatory agent and a proteasome inhibitor
  8. Meets all IMWG 2014 criteria at diagnosis or at time of current relapse
  9. Measurable disease
  10. 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
  11. 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
  12. 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)
  13. Adequate organ function as indicated by neutrophils, platelets, hemoglobin, eGFR, serum total and direct bilirubin, AST, ALT, INR, aPTT

Exclusion Criteria:

  1. 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.
  2. Received an anti-CD38 therapy within four months from first dose of study drug
  3. 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)
  4. 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
  5. 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.
  6. Non-secretory myeloma unless measurable plasmacytoma
  7. Known hypersensitivity to CID-103 excipients or prior severe hypersensitivity to a monoclonal antibody
  8. Baseline interval between Q and T wave on electrocardiogram > 480 msec using Fridericia's formula (QTcF)
  9. Requires renal dialysis
  10. Sensory or motor neuropathy ≥ Grade 3
  11. Known/clinically significant amyloidosis
  12. Known active central nervous system disease or leptomeningeal plasmacytoma.
  13. Presence of any other active malignancy requiring systemic therapy other than the disease under study
  14. Active infection requiring systemic therapy
  15. Active infection with human immunodeficiency virus and CD4+ T-cell count < 350/μL
  16. Active infection with hepatitis B (surface antigen); or infection with hepatitis C in absence of sustained virologic response
  17. Therapeutic anticoagulation, meaning any thromboembolic event within the last six months prior to first dose of study drug or anticoagulation with therapeutic (non-prophylactic) intent
  18. A history or evidence of cardiovascular risk
  19. History or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, particularly any pre-existing condition that would put the patient at additional risk should they experience an infusion-related reaction
  20. At the time of signing informed consent is a regular user (including "recreational/medical use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758767


Contacts
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Contact: Pauline Guihaire +33 (2) 99 59 91 91 CASI-CID-103-101@biotrial.com
Contact: Lesley Skingley +1 905 690 1200 lesley.skingley@bexonclinical.com

Locations
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France
CHU de Nantes - Hôpital Hôtel-Dieu Recruiting
Nantes, France
Contact: Cyrille Touzeau, MD         
CHU Rennes - Pontchaillou Recruiting
Rennes, France
Contact: Olivier Decaux, MD         
Gustave Roussy Cancer Center Recruiting
Villejuif Cedex, France
Contact: Jean-Marie Michot, MD         
United Kingdom
Sarah Cannon Recruiting
London, United Kingdom
Contact: Mary Gleason, MD         
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Alexander Zukiwski, MD CASI Pharmaceuticals, Inc.
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Responsible Party: CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04758767    
Other Study ID Numbers: CASI-CID-103-101
2019-004006-10 ( EudraCT Number )
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CASI Pharmaceuticals, Inc.:
multiple myeloma
CID-103
anti-CD38 antibody
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases