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

niversitätsklinikum Würzburg0 sites38 target enrollmentJuly 11, 2022

Overview

No summary available.

Registry

who.int

Start Date

July 11, 2022

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversitätsklinikum Würzburg

•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 an anti\-CD38 antibody.
•(Note: Induction therapy, up to 2 cycles of high\-dose chemotherapy with autologous hematopoietic stem cell transplantation, and subsequent consolidation and/or maintenance therapy are considered one line of treatment).
•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

•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 immune\-suppressants (e.g. cyclosporine or systemic steroids at any dose).
•(Note: Physiologic steroid replacement therapy, and topical steroids are permitted.)
•6\. Echocardiogram with left ventricular ejection fraction \<45%.