C90.0
Conditions
Interventions
Group 1: T1367 T Cells
Cyclophosphamid 300 mg / m² for 3 days
Fludarabin 30 mg / m² for 3 days
Sponsors
Charité Campus Berlin Buch
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. A diagnosis of relapsed and/or refractory MM requiring systemic therapy. 2. At least three prior therapy lines including proteasome inhibitors, alkylating drugs, immunomodulatory drugs and antibodies alone or in combination. Induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen. 3. Expression of MAGE-A1 on more or equal than 30 % of myeloma cells by immunohistochemistry in a bone marrow biopsy or biopsy of extramedullary manifestation. The analysis of archival material not older than six months is permitted for MAGE-A1 testing unless a systemic treatment for MM has been administered after biopsy (except Corticosteroids). 4. Minimal life expectancy of 3 months. 5. HLA-A*02:01 genotype. 6. Age =18 years 7. Agree to use safe contraception 8. At least 14 days from prior therapy line at leukapheresis 9. ECOG performance status 0-2 10. Adequate cardiopulmonary, renal and hepatic function a. No dyspnea at rest b. ALT, AST = 3 x ULN c. LVEF = 35 % d. Creatinine clearance =30 ml/min according to Cockcroft and Gault equation e. Total bilirubin = 1.5 x ULN except in case of Gilbert’s disease 11. Ability to understand and sign the Informed Consent Form
Exclusion criteria
Exclusion criteria: 1. History of allogeneic stem cell transplantation 2. Treatment with any prior gene therapy or gene-modified cellular immunotherapy 3. HIV infection 4. Active or chronic Hepatitis 5. Have any active and uncontrolled infection 6. Known or suspected hypersensitivity or intolerance to the IMP, Cyclophosphamide, Fludarabine, any other excipient and Tocilizumab. 7. Pregnancy or lactation: Females are eligible to participate if not pregnant and not breastfeeding. 8. Inadequate venous access for or contraindications to leukapheresis. 9. Any other condition requiring high-dose corticosteroid treatment in the two weeks prior to leukapheresis. 10. Juvenile rheumatoid arthritis, active rheumatoid arthritis or other active inflammatory joint diseases. 11. Subjects who are legally institutionalized, or subjects under judicial protection 12. Subjects with an immediate family member (i.e., spouse, parent/legal guardian, sibling or a child) being a member of study site staff or being a member of the sponsor’s study team. 13. Participation in another clinical trial, except for observational studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single escalating doses of autologous T cells modified to express the MAGE-A1-specific TCR T1367 for patients with relapsed/refractory Multiple Myeloma | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize T1367 T cells with respect to their in vivo expansion and persistence. To evaluate the impact of T1367 T cells on disease activity. To evaluate the impact of T1367 T cells on survival. | — |
Countries
Germany
Contacts
Public ContactMatthias Obenaus
Charité Campus Benjamin Franklin
Outcome results
None listed