Cellectis has provided an update on three clinical trials AMELI-01, BALLI-01 and NATHALI-01 evaluating its three chimeric antigen receptor (CAR) T-cell therapies UCART123, UCART22, and UCART20x22, respectively.
CAR-T cell therapies have been identified as a key immune-oncology innovation area by GlobalData. There are only six US Food and Drug Administration (FDA) approved CAR-T therapies.
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UCART123 clinical trial update
UCART123 is an allogeneic CAR-T therapy that targets CD123. It is being evaluated in an open-label dose-escalation Phase I AMELI-01 clinical trial (NCT03190278) in patients with relapsed or refractory (r/r) acute myeloid leukaemia (AML).
The data reported sustained lymphodepletion and significantly higher UCART123 cell expansion, indicating improved anti-tumour activity following the addition of alemtuzumab to fludarabine, cyclophosphamide, and UCART123 regimen.
Initial data from the trial was presented on 17 May 2023 at the American Society of Gene and Cell Therapy (ASGCT) 2023 annual meeting. The trial is currently open for patient enrolment.
UCART22 clinical trial update
UCART22 is an allogeneic CAR T-cell therapy that targets CD22. It is currently under evaluation in an open-label Phase I/II BALLI-01 clinical trial (NCT04150497) for the treatment of adult patients with r/r B-cell acute lymphoblastic leukaemia (B-ALL).
The data from Collectis’ lead candidate showed that the drug was well tolerated, with no dose-limiting toxicities and serious adverse events.
The study is currently open for patient enrolment. The first data from the study was presented on 9 June 2023 at European Haematology Association (EHA), with additional data expected in late 2023.
UCART20x22 clinical trial update
UCART20x22 is a dual allogeneic CAR-T therapy that targets both CD20 and CD22. It is currently being evaluated in an open-label Phase I/II NATHALI-01 clinical trial (NCT05607420) for the treatment of r/r AML. The data from the study is expected in late 2023.
The pre-clinical data for UCART20x22 was published in May 2023 showing a sustained and dose-dependent effect of the drug in primary non-Hodgkin lymphoma.
Cellectis reported having $89m in cash reserves as of 30 June 2023, compared to $95m cash reserves on 31 December 2022. The reported revenue and income for H1 2023 was $5.6m, with a market cap of $108.39m.
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