Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: IMN-006 (anti-BCMA CAR positive T cells): Dose: 0.3 million to 3 million CAR positive T cells per kg body weight
Route of administration: Intravenous
Frequency: Infusion is administered
Sponsors
Immuneel Therapeutics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: >= 18 years 2. ECOG 0 or 1 3. Relapsed or refractory disease and have had at least one prior line of therapy including proteasome inhibitor and immunomodulatory therapy. 4. Must have measurable disease (IMWG 2016) 5. Recovery to Other inclusion/exclusion criteria apply.
Exclusion criteria
Exclusion criteria: 1. Prior exposure to BCMA targeted therapy, gene therapy or T cell engager antibody molecule (TEAM) 2. Prior systemic therapy for MM within 14 days of leukapheresis / LD chemo 3. Symptomatic AL amyloidosis 4. Known central nervous system disease 5. Inadequate cardiac, renal, hepatic, bone marrow function 6. Active infection within 72 hours prior to lymphodepletion 7. Allogeneic bone marrow transplantation or ongoing treatment with chronic immunosuppressants 8. Significant co-morbidities 9. Pregnant/lactating women Other inclusion/exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of IMN-006 as determined by adverse events up to 3 months â?¢ Overall Response Rate (ORR) rate in the first 3 months of the first doseTimepoint: Baseline, 3 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Safety of IMN-006 as determined by adverse events up to 12 months â?¢ Overall Response Rate (ORR), Minimal residual disease (MRD) negative responses, Progression-free survival (PFS), Duration of Response (DOR), Overall survival (OS) and Time to Best ResponseTimepoint: 3, 6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Neera Gupta
Immuneel Therapeutics Pvt Ltd
Outcome results
None listed