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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CASI Pharmaceuticals, Inc.

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

9. Measurable disease

10. If female, must be of non-childbearing potential or have a negative pregnancy test at screening and use adequate contraception throughout study until 90 days after last dose

11. If male with partner of childbearing potential, be vasectomized or use 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, investigational drug or biological cancer therapy within three 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 or lack of available baseline data on RBC phenotype or genotype

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 or any of its excipients

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)