AzTrials
AzTrials

Multiple MyelomaPhase 1NCT04758767

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

A Phase 1 study testing CID-103 in people with Multiple Myeloma, run by CASI pharmaceuticals, Inc. at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
CID-103
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesin 2 countries
Study dates
22 Mar 2021to 19 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • Active infection with hepatitis B (surface antigen); or infection with hepatitis C in absence of sustained virologic response
  • 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
  • A history or evidence of cardiovascular risk
  • 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
  • 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)

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

France3 sites

  • CHU de Nantes - Hôpital Hôtel-Dieu

    Nantes

  • CHU Rennes - Pontchaillou

    Rennes

  • Gustave Roussy Cancer Center

    Villejuif

Other trials in France

United Kingdom1 site

  • Sarah Cannon

    London

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
CID-103
Keywords
multiple myeloma, CID-103, anti-CD38 antibody
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CID-103Drug

    anti-CD38 antibody

Study groups in NCT04758767
Study groupRoleWhat they receive
Dose escalation cohortExperimentalMonotherapy CID-103. Priming dose will be given for first dose. Dose and duration of infusion dependent on dose cohort and tolerability.
Receives: Drug: CID-103
Dose expansion cohort - pretreatedExperimentalCID-103 monotherapy at the recommended phase 2 dose
Receives: Drug: CID-103
Dose expansion cohort - NaïveExperimentalCID-103 monotherapy at the recommended phase 2 dose
Receives: Drug: CID-103

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    CTCAE v5 coded using the current Medical Dictionary for Regulatory Activities (MedDRA) version

    Measured: approximately 18 months after study start

Secondary outcomes (12)

  1. Recommended Phase 2 dose

    Based primarily on dose-limiting toxicities

    Measured: approximately 18 months after study start

  2. Optimal pre- and post-medication regimens

    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

    Measured: approximately 18 months after study start

  3. Target engagement assays and ex vivo testing

    Extent of RBC binding and cross-match confounding

    Measured: approximately 18 months after study start

  4. PK - AUC of CID-103

    AUC of CID-103 in serum

    Measured: approximately 18 months and 3 years after study start

  5. PK - Cmax of CID-103

    Cmax of CID-103 in serum

    Measured: approximately 18 months and 3 years after study start

  6. PK - t1/2 of CID-103

    half-life of CID-103 in serum

    Measured: approximately 18 months and 3 years after study start

  7. PK - Vd of CID-103

    volume of distribution of CID-103 in serum

    Measured: approximately 18 months and 3 years after study start

  8. PK - accumulation of CID-103

    accumulation of CID-103 in serum

    Measured: approximately 18 months and 3 years after study start

  9. Objective response rate

    Based on IMWG

    Measured: approximately 3 years after study start

  10. Duration of response

    Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG

    Measured: approximately 3 years after study start

  11. Progression-free survival

    Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG

    Measured: approximately 3 years after study start

  12. Overall survival

    Calculated using a Kaplan-Meier method overall and for appropriate subgroups and cohorts, based on IMWG

    Measured: approximately 3 years after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start22 Mar 2021
  3. Primary completion19 Jan 2023
  4. Study completion19 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Single arm dose escalation, followed by dose expansion arm (2 cohorts)
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04758767
Sponsor's protocol ID
CASI-CID-103-101
Other IDs
2019-004006-10, 2019
Status last verified
Apr 2025
First submitted
8 Feb 2021
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CID-103 in people with Multiple Myeloma, run by CASI pharmaceuticals, Inc. at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: approximately 18 months after study start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04758767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in