Study of CART-ddBMCA in Relapsed or Refractory Multiple Myeloma (iMMagine-1)
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|ClinicalTrials.gov Identifier: NCT05396885|
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : December 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: CART-ddBCMA||Phase 2|
This is a Phase II open-label study of CART-ddBCMA* in patients with relapsed or refractory multiple myeloma (MM). The study will have the following sequential phases: screening, enrollment, pre-treatment with lymphodepleting chemotherapy, treatment with CART-ddBCMA, and follow-up. If necessary, bridging therapy is allowed to control growth of MM disease while CART-ddBCMA is being manufactured.
Following a single infusion of CART-ddBCMA both safety and efficacy data will be assessed. Efficacy will be assessed monthly for the first 6 months, then quarterly up to 2 years, or upon patient relapse. The primary analysis will be conducted approximately 13 months after the final patient is dosed. This will allow approximately 12 months follow up from the time of the last observed response on study.
Long-term safety data will be collected under a separate long-term follow up study for up to 15 years per health authority guidelines.
*CART-ddBCMA drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor (CAR), followed by a cluster of differentiation 8 (CD8) hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ξ, that specifically recognizes B-cell maturation antigen (BCMA). The active substance of CART-ddBCMA is CAR+ CD3+ T cells that have undergone ex vivo T-cell activation, gene transfer by replication-deficient lentiviral vector, and expansion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||August 9, 2022|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||May 31, 2025|
Single dose of 115±10 x 10e-6 CAR+ CART-ddBCMA cells infused intravenously
BCMA-directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-domain
- Overall Response Rate (ORR) [ Time Frame: 24 Months ]ORR Per International Myeloma Working Group (IMWG) criteria, as assessed by an independent review committee (IRC)
- Stringent complete response (sCR) or complete response (CR) rate [ Time Frame: 24 Months ]The proportion of subjects in whom best response of sCR or CR, by IMWG criteria
- Overall Response Rate (ORR) of subjects limited to three lines of prior treatment [ Time Frame: 24 Months ]ORR per IMWG criteria, as assessed by an independent review committee (IRC), of subjects limited to three lines of prior treatment
- Duration of Response (DoR) [ Time Frame: 24 Months ]Time from the date of first documentation of response of PR or better per IMWG criteria after CART-ddBCMA infusion to the earlier of first documentation of disease progression per IMWG criteria or death
- Very Good Partial Response (VGPR) Rate and Partial Response (PR) Rate [ Time Frame: 24 Months ]The proportion of subjects with best response of VGPR and PR, respectively, by IMWG criteria
- Time to Initial Response [ Time Frame: 24 months ]Time to initial response measurement of time (e.g., days or months) from the date of infusion of CART-ddBCMA to the date upon which the first IMWG response (i.e., PR or better) occurs
- Progression Free Survival (PFS) [ Time Frame: 24 Months ]Measurement of time (e.g., days or months) from the date of infusion of CART-ddBCMA to the date upon which the IMWG criteria for progressive disease or death occurs
- Overall Survival (OS) [ Time Frame: 24 Months ]Measurement of time (e.g., days or months) from the date of infusion of CART-ddBCMA to the date upon which death from any cause occurs
- Safety Profile of CART-ddBCMA [ Time Frame: 24 Months ]Summarization of adverse event (AE) terms, frequency, and severity using CTCAE version 5.0, the adverse events of special interest (AESIs), the serious adverse events (SAEs)
- Define the Pharmacokinetics of CART-ddBCMA [ Time Frame: 24 Months ]Quantification of CART-ddBCMA cells using vector copy number (VCN) on peripheral blood mononuclear cells
- Anti-CART-ddBCMA Antibodies [ Time Frame: 24 Months ]Proportion of subjects who develop antibodies against CART-ddBCMA and the timing and titer of antibodies developed
- Health Related Quality of Life (HRQoL) [ Time Frame: 24 Months ]Measure the change in HRQoL pre- versus post-treatment with CART-ddBCMA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05396885
|Contact: Juliette Beaulieuemail@example.com|