Drugs / UCART19
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02735083 | Mar 2021 → Sep 2028 expected | lymphoid leukemia | Servier | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02746952 | Aug 2016 → Jul 2020 | B-cell acute lymphoblastic leukemia | Servier | Completed | No outcome recorded |
| Phase 1 | NCT02808442 | Jun 2016 → Sep 2020 | B-cell acute lymphoblastic leukemia | Servier | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-12-15 | Cellectis S.A. | Regulatory Cellectis Announces Arbitral Decision in Dispute with Servier cellectis.com ↗
The Tribunal ruled on a partial termination of the License Agreement with respect to product UCART19 V1 (also referred to as “ALLO-501” by Allogene) and provided that Cellectis shall, at Allogene’s request, engage in good-faith discussions regarding the granting of a direct license to product UCART19 V1. |
| 2018-12-03 | Allogene Therapeutics | Results Allogene Therapeutics and Servier Present Pooled Data from Phase 1 Trials of Allogeneic UCART19 in Relapsed/Refractory Acute Lymphoblastic Leukemia allogene.com ↗
The analysis showed that 82 percent (14/17) of patients who received a lymphodepletion regimen consisting of fludarabine, cyclophosphamide and an anti-CD52 mAb (FCA) achieved a complete remission (CR) or complete remission with incomplete blood recovery (CRi). |
| 2017-12-12 | Cellectis S.A. | Results Preliminary Data from Servier and Pfizer’s UCART19 Product Candidate Shows High Complete Remission Rate Across Two Phase I Adult and Pediatric Acute Lymphoblastic Leukemia Trials cellectis.com ↗
These first-in-human data demonstrated the safety and tolerability of UCART19, resulting in an 83% complete remission rate across the adult and pediatric patient population. |
| 2017-03-09 | Cellectis S.A. | Regulatory Servier and Pfizer announce FDA clearance of IND application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia cellectis.com ↗
9 March 2017 – Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Alternext: ALCLS; Nasdaq: CLLS), announced today that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational New Drug (IND) clearance to proceed in the U.S. with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia. |
| 2017-03-08 | Pfizer | Regulatory Servier and Pfizer Announce FDA Clearance of IND Application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia pfizer.com ↗
With this IND clearance, the CALM study will be expanded to include several centers in the U.S., including the MD Anderson Cancer Center in Houston (Texas). |
| 2015-12-23 | Cellectis S.A. | Regulatory Cellectis Files First Clinical Trial Application for UCART19, an Allogeneic Gene Edited CAR T-Cell Product for Hematological Malignancies cellectis.com ↗
Cellectis (Alternext: ALCLS – Nasdaq: CLLS) today announced the submission of a clinical trial application (CTA) to the Medicines & Healthcare products Regulatory Agency (MHRA) requesting approval to initiate UCART19 First-in-Human clinical investigation in leukemia in the United Kingdom. |
| 2014-06-23 | Cellectis S.A. | Regulatory Cellectis’ UCART19 receives Advanced-Therapy medicinal Product classification from EMA cellectis.com ↗ |
| 2013-07-04 | Cellectis S.A. | Results Cellectis Group announces groundbreaking in vivo proof of concept testing of their flagship UCART19 product for curative therapy of leukemia cellectis.com ↗
The results obtained show that the UCART19 product was able to eradicate human leukemia cells that had been transferred into mice, effectively curing the mice of tumors, and that the engineered T-cells performed as well as traditional CAR T-cells. |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | UCART19 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02808442 ↗ |
| Modality | Cell therapy | “Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor” NCT02735083 ↗ |
| Route | Intravenous | “received UCART19 doses of 6 × 106, 6-8 × 107, or 1·8-2·4 × 108 total CAR T cells intravenously” PMID 36228643 ↗ Oct 2022 |
| Target | CD19 | “Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor” NCT02735083 ↗ |