A study to test a new type of treatment for Myeloma. In this new treatment the blood cells of patients are modified to kill Myeloma cells on their ow
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2023/09/057329
- Lead Sponsor
- Immuneel Therapeutics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 = Grade 1 or baseline of any non-hematologic toxicities, excluding alopecia and Grade 2 neuropathy.
Other inclusion/exclusion criteria apply.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of IMN-006 as determined by adverse events up to 3 months <br/ ><br>• Overall Response Rate (ORR) rate in the first 3 months of the first doseTimepoint: Baseline, 3 months and 12 months
- Secondary Outcome Measures
Name Time Method • Safety of IMN-006 as determined by adverse events up to 12 months <br/ ><br>• 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