Status:
TERMINATED
APRIL CAR T Cells (AUTO2) Targeting BCMA and TACI for the Treatment of Multiple Myeloma
Lead Sponsor:
Autolus Limited
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test the safety and efficacy of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma.
Detailed Description
The study will consist of 2 phases, a Phase I/dose escalation phase and a Phase II/expansion phase. Patients with relapsed and relapsed or refractory multiple myeloma will be enrolled in both phases o...
Eligibility Criteria
Inclusion
- Key
- Male or female patients, aged ≥ 18.
- Willing and able to give written, informed consent.
- Confirmed diagnosis of MM.
- Measurable disease as defined by IMWG.
- Relapse or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor, alkylator and immunomodulatory therapy (IMiD), or have "double refractory" disease to a proteasome inhibitor and IMiD.
- For females of childbearing potential, a negative serum or urine pregnancy test must be documented at screening and confirmed before receiving study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
- Peripheral blood total lymphocyte count \> 0.5 x 10⁹/L.
- Key
Exclusion
- Women who are pregnant or lactating.
- Prior treatment with investigational or approved gene therapy or cell therapy products.
- Patient has previously received an allogenic stem cell transplant.
- Clinically significant, uncontrolled heart disease or a recent (within 6 months) cardiac event.
- Left Ventricular Ejection fraction \< 50 unless the institutional lower limit of normal is lower.
- Significant liver disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN, or total bilirubin \> 2.0 mg/dL or evidence of end stage liver disease (e.g. ascites, hepatic encephalopathy).
- Chronic renal impairment requiring dialysis, or calculated creatinine clearance \< 30 mL/min
- Active infectious bacterial or viral disease (hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human T-lymphotropic virus or syphilis) requiring treatmenUse of rituximab within the last 3 months.
- Active autoimmune disease requiring immunosuppression.
- Received any anti-myeloma therapy within the last 21 days prior to preconditioning or 10 days prior to leukapheresis; steroids of up to 160 mg of dexamethasone are permitted so long as \> 7 days post-dose prior to pre-conditioning or leukapheresis.
- Known allergy to albumin, dimethyl sulfoxide (DMSO), cyclophosphamide or fludarabine.
Key Trial Info
Start Date :
May 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03287804
Start Date
May 5 2017
End Date
September 5 2019
Last Update
October 23 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
VU University Medical Centre Amsterdam
Amsterdam, Netherlands
2
University College London Hospitals NHS Foundation Trust
London, United Kingdom
3
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
4
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom