CASI-CID-103-101
Research type
Research Study
Full 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
IRAS ID
278216
Contact name
Mary Gleeson
Contact email
Sponsor organisation
CASI Pharmaceuticals, Inc
Eudract number
2019-004006-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Research Summary
This study aims to evaluate the safety and tolerability of CID-103 in patients with previously treated relapsed/ refractory multiple myeloma in men or women ≥18 years of age who meet the inclusion criteria and none of the exclusion criteria.
Lay summary of study results
Study Identification: Full study title: A phase 1 dose escalation and expansion study of CID-103, an anti-CD38 antibody, in patients with previously treated relapsed and/or refractory multiple myeloma Short study title: CASI-CID-103-101 IRAS ID: 278216 REC reference: 21/LO/0317 EudraCT number: 2019‐004006‐10 Abstract: Purpose of the study: first-in-human study to determine if CID-103 is safe to use and tolerable in patients with previously treated relapsed and/or refractory multiple myeloma. What was tested: the safety and tolerability of CID-103 at different doses was tested in a small number of patients. People taking part: 10 patients aged 18 years and older with previously treated relapsed and/or refractory multiple myeloma took part in this trial across 2 countries. Results: The study was stopped early. Researchers found that CID-103 was safe and well tolerated at all doses tested. Study Sponsor: The sponsor of this study was CASI Pharmaceuticals, Inc. who would like to thank everyone who took part. The study sponsor can be contacted via email at alexz@casipharmaceuticals.com. General Information: The purpose of this Phase 1 study was to determine if CID-103 is safe to use and tolerable in patients with a certain type of cancer known as multiple myeloma. The safety and tolerability of CID-103 at different doses was tested in a small number of patients with previously treated relapsed and/or refractory multiple myeloma. CID-103 has never been tested in humans before. Overall, 10 patients aged 18 years and older with previously treated relapsed and/or refractory multiple myeloma took part in this trial in France and the UK. The study started on 27th March 2021 and ended on 19th January 2023. The study was stopped early due to difficulties in recruiting patients due to changes in the standard care of patients with multiple myeloma and a large number of investigative agents in various stages of clinical trials being investigated in patients with multiple myeloma. In this study, researchers found that CID-103 given as 30 mg/150 mg, 150 mg/300 mg, 150 mg/600 mg and 150 mg/900 mg doses was generally safe and well-tolerated overall. Treatments: As this was a Phase 1 study, all patients received the study drug, CID-103, which was given via a vein. This study was open label meaning that doctors and patients knew the identification of the study drug and the amount of CID-103 given to each patient. It was a non-randomized trial meaning patients were assigned to one of the open dose levels on a “first-come, first-served” basis. Medical Problems: Side effects are unwanted medicinal events (such as a headache) that happen during the study and are reported because the trial doctor (investigator) believes the side effects were related to the treatments in the trial. Not all the patients in this trial had side effects. Serious side effects are reactions that are life threatening or require the individual to be admitted to the hospital. Serious and common side effects are listed here: Side effects in the 30 mg/150 mg group included (one patient enrolled): - 2 events (1 event was considered serious) of low number of platelets in the blood (thrombocytopenia) (1 patient; 100%) - 1 event of too much fluid in the body (fluid overload) (1 patient; 100%) - 1 event of low number of white blood cells (neutropenia) (1 patient; 100%) Side effects in the 150 mg/300 mg group included (one patient enrolled): - 1 event of constipation (1 patient; 100%) - 1 event of low number of red blood cells (anemia) (1 patient; 100%) Side effects in the 150 mg/600 mg group included (3 patients enrolled): - 2 events of low number of red blood cells (anemia) (1 patient, 33.3%) - 2 events of higher than normal calcium level in the blood (hypercalcemia) (1 patient, 33.3%) - 1 event of strong immune response to a cancer treatment that's given intravenously. Symptoms can include fever, chills, nausea (infusion-related reaction) (1 patient, 33.3%) - 1 event of high levels of the digestive enzyme amylase in the blood or urine (increased amylase) (1 patient, 33.3%) - 1 event of dehydration (1 patient, 33.3%) - 1 event of low levels of potassium in the blood (hypokalemia) (1 patient, 33.3%) - 1 event of diarrhea (1 patient, 33.3%) - 1 event of bleeding from the rectum or anus (rectal hemorrhage) (1 patient, 33.3%) - 1 event of vomiting (1 patient, 33.3%) - 1 event of physical weakness and/or a lack of energy and strength (asthenia) (1 patient, 33.3%) - 1 event of pain or discomfort in the bones or joints (bone pain) (1 patient, 33.3%) - 1 event of overreaction of body’s immune system in response to an infection (sepsis) (1 patient, 33.3%) Side effects in the 150 mg/900 mg group included (5 patients enrolled): - 11 events (3 events were considered serious) of low number of platelets in the blood (thrombocytopenia) (2 patients, 40%) - 6 events of low number of red blood cells (anemia) (3 patients, 60%) - 4 events of low number of white blood cells (neutropenia) (2 patients, 40%) - 2 events of low levels of potassium in the blood (hypokalemia) (2 patients, 40%) - 2 events of feeling of tingling, numbness or “pins and needles” usually in the hands, arms and legs or feet (paresthesia) (1 patient, 20%) - 2 events of COVID-19 (2 patients, 40%) - 1 event of collection of blood between the skull and the surface of the brain (subdural hematoma) (1 patient, 20%) - 1 event of pain or discomfort in the bones or joints (bone pain) (1 patient, 20%) - 1 event of any problem in the lungs that prevents the lungs from working properly (lung disorder) (1 patient, 20%) - 1 event of chills (1 patient, 20%) - 1 event of increase in the body temperature above normal (pyrexia) (1 patient, 20%) - 1 event of inflammation of the outer lining of the eye (conjunctivitis) (1 patient, 20%) - 1 event of oral herpes (1 patient, 20%) - 1 event of injury to the eye (eye contusion) (1 patient, 20%) - 1 event of high blood levels of an enzyme which is found in the liver (increased alanine aminotransferase (ALT)) (1 patient, 20%) - 1 event of high lives of an enzyme that helps the liver convert food into energy (increased aspartate aminotransferase (AST)) (1 patient, 20%) - 1 event of nosebleeds (epistaxis) (1 patient, 20%) Side effects that were thought to be related to study treatment and which occurred in more than 1 patient (at any dose level) were as follows: - low number of platelets in the blood (thrombocytopenia), with 8 events (2 patients in 150 mg/900 mg cohort; 40% of cohort) - Low number of white blood cells (neutropenia), with 2 events (2 patients in 150 mg/900 mg cohort; 40% of cohort) Across all dose levels, the most frequent adverse event reported was anemia, with one event in one (100%) patient in the 150 mg/300 mg group, two events in one (33.3%) patient in the 150 mg/600 mg group and six events in three (60%) patients in the 150 mg/900 mg group. There were no serious side effects deemed related to study drug. Results: This trial was undertaken to see if CID-103 could be given safely. In addition, the study proposed to find the highest dose of treatment that people could safely use without having severe side effects and confirm the optimal treatment regimens. The study was stopped early due to difficulties in finding patients due to changes in the standard care of patients with multiple myeloma. Consequently, no patients received the highest two doses of CID-103 and the highest dose of treatment that people could safely use without having severe side effects was not established. The following safety results were found: - 17 side effects were believed to be related to the study drug. These occurred in 4 patients. - There were no severe/life-threatening side effects believed to be related to the study drug. - No significant changes related to the body’s basic functions were found. In this study, researchers found that CID-103 given as 30 mg/150 mg, 150 mg/300 mg, 150 mg/600 mg and 150 mg/900 mg doses was generally safe and well-tolerated overall. There was no beneficial impact of CID-103 on any patient’s multiple myeloma. Nine of the 10 study patients discontinued study drug due to progressive disease or lack of clinical benefit. The remaining patient discontinued study drug due to an unrelated side effect. Help: This treatment was tested only in patients with previously treated relapsed and/or refractory multiple myeloma. The main purpose of this study was to see if CID-103 is safe to use and tolerable in patients. Researchers look at the results of many studies to understand which drugs work and how they work. It takes lots of people in many studies all around the world to advance medical science. This summary only shows the results from this one study. The studies may find different results. You should not change your treatment based on the results of this study without first talking to your doctor/ healthcare professional providing your care about what these results might mean for you. Further Studies: No further clinical trials with CID-103 are planned at the current time. CID-103 may be studied for alternative conditions in the future. Learn More: To learn more about this study, you can find more detailed information on this website: Clinicaltrials.govREC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0317
Date of REC Opinion
18 Jun 2021
REC opinion
Further Information Favourable Opinion