Trial Search Results

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

The purpose of the Part A of the study is to determine if the studydrug CAEL-101 is well-tolerated when given at different amounts topeople with AL amyloidosis who are also receiving chemotherapy(chemical agents to treat AL amyloidosis).The purpose of study Part B is to determine if CAEL-101 is well toleratedwhen given to people with AL amyloidosis who are also receiving a chemotherapy treatment that includes daratumumab.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Caelum Biosciences

Stanford Investigator(s):

Intervention(s):

  • Drug: CAEL-101
  • Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)
  • Drug: Daratumumab

Phase:

Phase 2

Eligibility


Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study.

   1. Provide written informed consent and be willing and able to comply with all study
   procedures

   2. Adult, 18 years and older

   3. Minimum life expectancy of 6 months

   4. AL amyloidosis Mayo stage I, II, or IIIa at the time of Screening

   5. Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry
   and polarizing light microscopy of green bi-refringent material in Congo red stained
   tissue specimens (in an organ other than bone marrow) or characteristic electron
   microscopy appearance

   6. a. For Part A, currently on and continuing OR planned to start concurrent chemotherapy
   with CyBorD administered weekly as SoC.

   b. For Part B, currently on and continuing OR planned to start concurrent chemotherapy
   with CyBorD and daratumumab administered as SoC.

   7. Adequate bone marrow reserve and hepatic function as demonstrated by:

   8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
   during Screening and must agree to use effective physician-approved contraception from
   Screening to 90 days following the last study drug administration

   9. Men must be surgically sterile or must agree to use effective physician-approved
   contraception from Screening to 90 days following the last study drug administration

Exclusion Criteria:

Patients who meet any of the following criteria will not be permitted entry to the study.

   1. Any form of secondary, hereditary, senile, localized, dialysis-related or leukocyte
   chemotactic factor 2-related (ALECT2) amyloidosis

   2. Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma.

   3. Supine systolic blood pressure < 90 mmHg or symptomatic orthostatic hypotension,
   defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite
   medical management (e.g., midodrine, fludrocortisones) in the absence of volume
   depletion

   4. Taking prednisone or its equivalent > 10 mg/day

   5. Receiving dialysis

   6. Planned stem cell transplant during the first 6 months of protocol therapy.

   7. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular
   arrhythmias, or percutaneous cardiac intervention with recent stent, coronary artery
   bypass grafting or major cerebrovascular accident within 6 months prior to screening

   8. Left ventricular ejection fraction (LVEF) < 45 percent by echocardiogram or multigated
   acquisition scan (MUGA) within the last 6 months

   9. Severe valvular stenosis (e.g. aortic or mitral stenosis with a valve area <1.0 cm^2)
   or severe congenital heart disease

10. History of sustained ventricular tachycardia or aborted ventricular fibrillation or
   with a history of atrioventricular nodal or sinoatrial nodal dysfunction for which a
   pacemaker/implantable cardioverter-defibrillators (ICD) is indicated but not placed
   (participants who do have a pacemaker/ICD are allowed on study)

11. QTcF > 500 msec. Participants who have a pacemaker may be included regardless of
   calculated QTc interval.

12. Evidence of acute ischemia or active conduction system abnormalities with the
   exception of any of the following:

      1. First degree AV-block

      2. Second degree AV-block Type 1 (Mobitz Type 1/Wenckebach type)

      3. Right or left bundle branch block

      4. Atrial fibrillation with a controlled ventricular rate (uncontrolled [i.e., >110
      bpm] ventricular rate is not allowed [determined by an average of three beats in
      Lead II or representative beats if Lead II is not representative of the overall
      ECG])

13. Major surgery within 4 weeks of first dose or planned major surgery during the study.
   Patients with surgical procedures conducted under local anesthesia may participate.

14. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
   endocrinopathy, monoclonal protein [M-protein] and skin changes)

15. Active malignancy (including lymphoma) with the exception of any of the following:

      1. Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ
      cervical cancer

      2. Adequately treated Stage I cancer from which the patient is currently in
      remission and has been in remission for > 2 years

      3. Low-risk prostate cancer with Gleason score < 7 and prostate-specific antigen <
      10 mg/mL

16. Patients receiving an investigational drug/device in another clinical investigational
   study within 60 days before Screening

17. Nursing mothers will not be permitted entry into the study.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mani Gupta
650-723-0501
Recruiting