NCT02746952 (CALM) is a Phase 1 clinical trial of UCART19 in B-cell Acute Lymphoblastic Leukemia, sponsored by Institut de Recherches Internationales Servier.

Who is sponsoring NCT02746952?

NCT02746952 is sponsored by Institut de Recherches Internationales Servier.

What drugs are being tested in NCT02746952?

Interventions in NCT02746952: UCART19.

What condition does NCT02746952 study?

NCT02746952 studies B-cell Acute Lymphoblastic Leukemia.

Is NCT02746952 still recruiting?

NCT02746952 is currently completed. Last updated 1 October 2021.

Last reviewed 2021-10-01 · How we verify

NCT02746952: CALM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia

Completed Phase 1 Last updated 1 October 2021

What this trial tests

Phase 1 trial testing UCART19 in B-cell Acute Lymphoblastic Leukemia in 25 participants. Completed in 28 July 2020.

Timeline

1 August 2016

Primary endpoint
28 July 2020

28 July 2020

Quick facts

Lead sponsor	Institut de Recherches Internationales Servier
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 August 2016
Primary completion	28 July 2020
Estimated completion	28 July 2020
Sites	9 locations across France, Japan, United States, United Kingdom

Drugs / interventions tested

UCART19 — full drug profile →

Conditions studied

B-cell Acute Lymphoblastic Leukemia — all drugs for B-cell Acute Lymphoblastic Leukemia →

Sponsor

Institut de Recherches Internationales Servier — full company profile →

Who can join

Adults 16 to 69, any sex, with B-cell Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the dose escalation part is to evaluate the safety and tolerability of ascending doses of UCART19 (dose-escalation part) given as a single infusion in patients with relapsed / refractory (R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose (MTD), the recommended dose and the lymphodepletion regimen. The purpose of the safety dose expansion is to assess the safety and tolerability of the RD for UCART19.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Engineering strategies to overcome the current roadblocks in CAR T cell therapy.
Rafiq S, Hackett CS, Brentjens RJ. · · 2020 · cited 1111× · PMID 31848460 · DOI 10.1038/s41571-019-0297-y
Recent advances and discoveries in the mechanisms and functions of CAR T cells.
Larson RC, Maus MV. · · 2021 · cited 644× · PMID 33483715 · DOI 10.1038/s41568-020-00323-z
Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies.
Benjamin R, Graham C, Yallop D, Jozwik A, et al · · 2020 · cited 290× · PMID 33308471 · DOI 10.1016/s0140-6736(20)32334-5
Incorporation of Immune Checkpoint Blockade into Chimeric Antigen Receptor T Cells (CAR-Ts): Combination or Built-In CAR-T.
Yoon DH, Osborn MJ, Tolar J, Kim CJ. · · 2018 · cited 161× · PMID 29364163 · DOI 10.3390/ijms19020340
Nanomedicines to Deliver mRNA: State of the Art and Future Perspectives.
Gómez-Aguado I, Rodríguez-Castejón J, Vicente-Pascual M, Rodríguez-Gascón A, et al · · 2020 · cited 144× · PMID 32093140 · DOI 10.3390/nano10020364
Advances in Universal CAR-T Cell Therapy.
Lin H, Cheng J, Mu W, Zhou J, et al · · 2021 · cited 135× · PMID 34691052 · DOI 10.3389/fimmu.2021.744823
Allogeneic CAR-T Cells: More than Ease of Access?
Graham C, Jozwik A, Pepper A, Benjamin R. · · 2018 · cited 135× · PMID 30275435 · DOI 10.3390/cells7100155
Gene editing and CRISPR in the clinic: current and future perspectives.
Hirakawa MP, Krishnakumar R, Timlin JA, Carney JP, et al · · 2020 · cited 126× · PMID 32207531 · DOI 10.1042/bsr20200127

Verify or expand the search:

Other trials of UCART19

Trials testing the same drug.

NCT02808442 — Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia · Phase 1 · completed

Other recruiting trials for B-cell Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

NCT06326008 — Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-deri · Phase 1 · recruiting
NCT07153796 — A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemoth · Phase 2 · recruiting
NCT06863259 — Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL · Phase 1 · recruiting
NCT06793241 — Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia · EARLY_PHASE1 · recruiting
NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting

Other Institut de Recherches Internationales Servier trials

Trials by the same sponsor.

NCT07227857 — A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopath · Phase 1, PHASE2 · recruiting
NCT06501625 — Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Meta · Phase 1, PHASE2 · recruiting
NCT06465953 — Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelod · Phase 3 · recruiting
NCT06225999 — Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not · Phase 2 · active not recruiting
NCT05674474 — A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hep · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02746952 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut de Recherches Internationales Servier
Last refreshed: 1 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02746952.

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