A phase I/IIa clinical trial to assess feasibility, safety and antitumor activity of autologous SLAMF7 CAR-T cells in multiple myeloma - SLAMF7 CAR-T in multiple myeloma

niversitätsklinikum Würzburg0 sites38 target enrollmentAugust 2, 2021

ConditionsMultiple myeloma (MM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple myeloma (MM)
Sponsor: niversitätsklinikum Würzburg
Enrollment: 38
Status: Active, Not Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 2, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversitätsklinikum Würzburg

Eligibility Criteria

Inclusion Criteria

•1\. Signed informed consent form
•2\. Patient is \>\=18 years of age
•3\. Patient is willing and able to adhere to the protocol requirements
•4\. Patient with diagnosis of MM who has been treated with at least 2 prior lines of treatment, including at least one cycle of high\-dose chemotherapy with autologous hematopoietic stem cell transplantation if the patient was eligible, and exposure to an immunomodulatory imide drug (e.g. lenalidomide and/or pomalidomide), a proteasome inhibitor,
•and/or an anti\-CD38 antibody.
•5\. At least one of the following subcriteria must be measured in the patient:
•\- Serum M\-protein greater or equal to 0\.5 g/dL
•\- Urine M\-protein greater or equal to 200 mg/24 h
•\- Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
•\- A biopsy\-proven evaluable plasmacytoma

Exclusion Criteria

•1\. Patient has undergone a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning \<\=12 months prior to leukapheresis.
•2\. Patient has undergone a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning \>12 months, and suffers on chronic Graft\-versus\-Host Disease and/or is on systemic immune\-suppressants.
•3\. Patient with diagnosis of MM
•a. in first relapse following an autologous stem cell transplantation or
•b. in second relapse that subsequently achieves a complete response that is considered being a candidate for an allogeneic stem cell transplantation, unless the patient explicitly denies undergoing an allogeneic stem cell transplantation.
•4\. Patient has received anti\-CD38 and/or anti\-SLAMF7 antibodies \<\=8 weeks prior to leukapheresis.
•5\. Ongoing treatment with systemic immune\-suppressants (e.g. systemic cyclosporine or systemic steroids at any dose).
•6\. Echocardiogram with left ventricular ejection fraction \<45%.
•7\. Inadequate renal function defined by creatinine clearance \<\=45 mL/min using Cockcroft\-Gault equation.
•8\. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2\.5 x upper limit of normal (ULN) and total bilirubin \>1\.5 x ULN (unless due to Gilbert’s syndrome and direct bilirubin is \<\=1\.5 x ULN; unless due to intrahepatic myeloma lesions as demonstrated by magnetic resonance imaging \[MRI] or positron emission tomography \[PET]/computed tomography \[CT] not older than 4 weeks prior to screening).