Alemtuzumab
Monoclonal antibody targets CD52
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | LEMTRADA | — | 2007-09-19 – 2018-11-28 | fda.gov ↗ |
| Approved | EU (EMA) | MabCampath | — | 2001-07-06 | europa.eu ↗ |
| Approved | US (FDA) | LEMTRADA | — | 2001-05-07 | fda.gov ↗ |
Trials 213 · started per year
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Cellectis S.A. | Results Cellectis Presents Final Phase 1 Results of Lasme-cel and Preliminary Results on Eti-cel at EHA 2026 Congress cellectis.com ↗
These encouraging data demonstrate that not only can eti-cel drive responses in a very difficult-to-treat population, but that by optimizing exposure to alemtuzumab we may be able to create a favorable environment for CAR-T expansion and persistence. |
| 2025-11-03 | Cellectis S.A. | Results Cellectis to Present a Development Update for eti-cel at ASH 2025 cellectis.com ↗
Correlation between alemtuzumab exposure and response with lasme-cel (UCART22) allows optimization of efficacy without an increase in toxicities |
| 2025-08-01 | Allogene Therapeutics | Results Allogene Therapeutics Moves Forward with Standard Fludarabine and Cyclophosphamide (FC) Lymphodepletion Regimen in the ALPHA3 Trial for Cemacabtagene Ansegedleucel (Cema-Cel) in First-Line Consolidation for Large B-Cell Lymphoma allogene.com ↗
This decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647. |
| 2024-08-01 | Cellectis S.A. | Regulatory FDA Grants Orphan Drug Designation to Cellectis’ CLLS52 (alemtuzumab) For ALL Treatment cellectis.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Cellectis’ CLLS52 (alemtuzumab) |
| 2023-12-09 | Allogene Therapeutics | Results Allogene Therapeutics Presents Comprehensive Safety Data of Proprietary Lymphodepletion Agent ALLO-647 at the 65th Annual Meeting of the American Society of Hematology allogene.com ↗
The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy. |
| 2023-11-02 | Allogene Therapeutics | Results Allogene Therapeutics Announces Poster Presentations at the 65th Annual Meeting of the American Society of Hematology allogene.com ↗
These results reinforce our belief that Allogene’s strategy of adding ALLO-647, an anti-CD52 monoclonal antibody candidate, to the standard fludarabine/cyclophosphamide (flu/cy) lymphodepletion regimen in our ALPHA/ALPHA2 studies can safely achieve this, |
| 2023-05-02 | Cellectis S.A. | Results Cellectis Announces Oral Presentation on AMELI-01 and Poster Presentation on Multiplex Engineering for Superior Generation of CAR T-cells at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting cellectis.com ↗
The data show that adding alemtuzumab to the FC regimen was associated with improved LD and significantly higher UCART123 cell expansion, which correlated with improved activity. |
| 2022-11-29 | Allogene Therapeutics | Results Allogene Therapeutics R&D Showcase Features Hematologic and Solid Tumor Advances Across its AlloCAR T™ Platform allogene.com ↗
A single infusion of CAR+ cells with FCA90 lymphodepletion regimen consisting of fludarabine (30 mg/m2/day x 3 days) and cyclophosphamide (300 mg/m2/day x 3 days) (standard flu/cy) plus 90 mg of ALLO-647 (Single Dose FCA90) was deemed preferrable to two infusions of CAR+ cells (Consolidation Regimen). |
| 2022-11-03 | Cellectis S.A. | Results Cellectis to Showcase Clinical Data from AMELI-01 and Preclinical Data from UCARTCS1 at ASH 2022 cellectis.com ↗
AMELI-01 (evaluating UCART123) abstract, selected for oral presentation, highlights that adding alemtuzumab was associated with improved activity |
| 2021-12-11 | Cellectis S.A. | Results Cellectis Reports Encouraging Clinical Data from BALLI-01 Study in Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, and Preclinical Data from TALGlobin01 at the 63rd American Society of Hematology Annual Meeting cellectis.com ↗ |
| 2021-11-04 | Cellectis S.A. | Results Cellectis Provides Business Update and Reports Financial Results for Third Quarter and First Nine Months 2021 cellectis.com ↗
The data show that the addition of alemtuzumab to fludarabine and cyclophosphamide was well tolerated, deepened host T-cell depletion and promoted CAR-T cell expansion. |
| 2021-11-03 | Cellectis S.A. | Results Cellectis Announces Release of Abstracts at ASH Showcasing Updated Preliminary Clinical Data from BALLI-01 Study and First Preclinical Data from TALGlobin01 cellectis.com ↗
The data show that the addition of alemtuzumab to fludarabine and cyclophosphamide was well tolerated, deepened host T-cell depletion and promoted CAR-T cell expansion. |
| 2021-06-04 | Allogene Therapeutics | Results Allogene Therapeutics Presents Positive Phase 1 Data on ALLO-501 and ALLO-501A in Relapsed/Refractory Non-Hodgkin Lymphoma at the 2021 Annual Meeting of the American Society of Clinical Oncology allogene.com ↗
No dose limiting toxicities or graft-vs-host disease (GvHD) were observed and one (2%) case of Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was reported. |
| 2021-05-19 | Allogene Therapeutics | Results Allogene Therapeutics CD19 Forum Highlights Positive Results from Phase 1 Studies of ALLO-501 and ALLO-501A in Relapsed/Refractory Non-Hodgkin Lymphoma and Plan to Initiate Pivotal Study in 2021 allogene.com ↗
Safety and PK/PD Data of ALLO-647 with Flu/Cy Across ALPHA, ALPHA2 and UNIVERSAL (ALLO-715 in Multiple Myeloma) Trials Demonstrated Manageable Safety Profile; Exposure-Dependent Deep Lymphodepletion Correlated with AlloCAR T Cell Expansion and Clinical Responses |
| 2020-12-05 | Allogene Therapeutics | Results Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL Study of ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 62nd American Society of Hematology Annual Meeting allogene.com ↗
ALLO-715 with ALLO-647 Lymphodepletion Were Well Tolerated with No Graft-vs-Host Disease or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) |
| 2020-11-04 | Allogene Therapeutics | Results Allogene Therapeutics Announces Oral Presentation of Initial Results from its Phase 1 Dose Escalation Study of ALLO-715 in Relapsed/Refractory Multiple Myeloma at the 62nd Annual Meeting of the American Society of Hematology allogene.com ↗
Lower Dose (39mg) ALLO-647 Dose Dependent Activity Was Observed with 320M Cell Dose of ALLO-715 (DL3) Associated with a 60% Overall Response Rate (ORR) |
| 2020-05-29 | Allogene Therapeutics | Results Allogene Therapeutics, with Collaborator Servier, Reports Positive Results from its Phase 1 ALPHA Study of ALLO-501 in Relapsed/Refractory Non-Hodgkin Lymphoma at the American Society of Clinical Oncology Annual Meeting allogene.com ↗
ALLO-501 with ALLO-647 Lymphodepletion was Well Tolerated with No Dose-Limiting Toxicities, Graft-vs-Host Disease or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) |
| 2020-05-13 | Allogene Therapeutics | Results American Society of Clinical Oncology (ASCO) Abstract Reports Initial ALLO-501 ALPHA Phase 1 Data in Relapsed/Refractory Non-Hodgkin Lymphoma allogene.com ↗
Three Patients Achieved a Complete Response (CR) |
| 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). |
| 2005-12-09 | Astex Pharmaceuticals, Inc. | Results Studies of Nipent® in Combination Cancer Therapies for Treatment of Chronic Lymphocytic Leukemia and Graft-versus Host Disease (GVHD) Presented at American Society of Hematology Annual Meeting astx.com ↗
Combined Therapy with Alemtuzumab and Pentostatin Is Feasible and Effective in T- Lymphoprolifertive Disorders |
All press releases naming this drug 21 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 305 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alemtuzumab | “This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine...” NCT00943592 ↗244“Twenty-two children with a median age of 2.8 years, many with severe comorbidities and prior viral infections, were enrolled in a novel RIC protocol consisting of hydroxyurea,...” PMID 24296492 ↗ Dec 2013 “After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were...” NCT00147901 ↗ “The study examines different conditioning approaches that vary in the timing and dosing of alemtuzumab (Campath), as well as disease-specific modifications for beta thalassemia...” NCT01050855 ↗ “Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1.” NCT01049854 ↗ “Alemtuzumab (Campath®) is a humanized monoclonal antibody to CD52 that is FDA approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL)” NCT00331162 ↗ “Alemtuzumab: Children weighing 10 kg or more will receive 10 mg, 15 mg, and 20 mg intravenously (IV) on Days -21, -20, and -19, respectively” NCT00745420 ↗ “CAMPATH-1H (Alemtuzumab) is a recombinant DNA-derived humanized monoclonal antibody directed against the cell surface glycoprotein, CD52;” NCT00533923 ↗ “conditioning regimen of alemtuzumab/Campath, anti-thymocyte globulin/rabbit ATG, Fludarabine and Melphalan and total body irradiation” NCT07284641 ↗ “Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells.” NCT01909245 ↗ “Initial T-cell depletion with alemtuzumab is followed by upper extremity transplantation and tacrolimus maintenance therapy.” NCT01459107 ↗ |
| Known as | Alemtuzumab (Campath) | “Alemtuzumab (Campath®)” NCT00997386 ↗1“Alemtuzumab (Campath)” NCT01877837 ↗ |
| Known as | alemtuzumab (Campath, Lemtrada) | “alemtuzumab (Campath®, Lemtrada®)” NCT04047628 ↗ |
| Known as | ALLO-647 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05000450 ↗ |
| Known as | Campath | “Treatment of early relapsing-remitting multiple sclerosis with the lymphocyte-depleting humanized monoclonal antibody alemtuzumab (Campath [registered trade mark])...” PMID 20659956 ↗ Jul 201021“To determine the toxicity profile and tolerability of alemtuzumab (Campath) when administered in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone...” NCT00161590 ↗ “The study examines different conditioning approaches that vary in the timing and dosing of alemtuzumab (Campath), as well as disease-specific modifications for beta thalassemia...” NCT01050855 ↗ “This study will examine the safety and effectiveness of alemtuzumab (Campath® (Registered Trademark)) for improving muscle strength in patients with sporadic inclusion body...” NCT00079768 ↗ “CAMPATH (alemtuzumab, MABCAMPATH, CAMPATH) administered intravenously (IV) once a week as treatment for relapsing or refractory non-Hodgkin's lymphoma (NHL).” NCT00051701 ↗ “Alemtuzumab (Campath®) is a humanized monoclonal antibody to CD52 that is FDA approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL)” NCT00331162 ↗ “conditioning regimen of alemtuzumab/Campath, anti-thymocyte globulin/rabbit ATG, Fludarabine and Melphalan and total body irradiation” NCT07284641 ↗ “Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells.” NCT01909245 ↗ “Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days” NCT00206726 ↗ “Alemtuzumab is approved and sold under the brand names Campath and MabCampath to treat some types of leukemia.” NCT01333358 ↗ “An antibody therapeutic, Alemtuzumab (also know as Campath), that kills cells that make the CD52 protein” NCT00637390 ↗ |
| Known as | Campath-1H | “This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered...” NCT00001984 ↗69“To translate IL-15-mediated increases in NK cells, we investigated combination therapy of IL-15 with anticancer monoclonal antibodies including rituximab in mouse models of...” PMID 32508818 ↗ May 2020 “This study investigated the efficacy, safety, and clinical benefit of alemtuzumab (Campath-1H) for patients with relapsed or refractory B-cell chronic lymphocytic leukemia...” PMID 11986207 ↗ May 2002 “The purpose of this study is to evaluate the use of alemtuzumab (Campath-1H) for induction therapy in kidney and pancreas transplantation compared to our standard of care,...” NCT00331162 ↗ “Alemtuzumab (Campath-1H) is a humanized monoclonal antibody that targets CD52, a cell surface protein present at high density on most normal and malignant B and T lymphocytes.” NCT00930605 ↗ “Campath-1H (alemtuzumab) given subcutaneously during post-remission intensification treatment of adults with acute lymphoblastic leukemia (ALL).” NCT00061945 ↗ “CAMPATH-1H is used to prevent participants from rejecting or refusing to let the donor blood cells grow in the body.” NCT00040469 ↗ “A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL” NCT00858117 ↗ “Our group has combined the above combination of fludarabine and cyclophosphamide with the antibody CAMPATH 1H.” NCT00578942 ↗ “Our group has combined the above combination of fludarabine and cyclophosphamide with the antibody CAMPATH 1H.” NCT00580034 ↗ “Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma” NCT00193466 ↗ |
| Known as | Campath-1H (Alemtuzumab) | “Campath-1H (Alemtuzumab)” NCT01172418 ↗ |
| Known as | Campath-IH | “Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.” NCT00142181 ↗1“Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17” NCT02435901 ↗ |
| Known as | Lemtrada (alemtuzumab) | “Lemtrada (alemtuzumab)” NCT03535298 ↗ |
| Known as | Mab- Campath (Alemtuzumab) | “Mab- Campath (Alemtuzumab)” NCT01679860 ↗ |
| Known as | MabCampath | “CAMPATH (alemtuzumab, MABCAMPATH, CAMPATH) administered intravenously (IV) once a week as treatment for relapsing or refractory non-Hodgkin's lymphoma (NHL).” NCT00051701 ↗5“Alemtuzumab is approved and sold under the brand names Campath and MabCampath to treat some types of leukemia.” NCT01333358 ↗ “Consolidation Therapy With Alemtuzumab (MabCampath®) in Patients With Chronic Lymphocytic Leukemia” NCT00634881 ↗ “Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil” NCT00046683 ↗ “the monoclonal antibody MabCampath® (alemtuzumab)” NCT00646854 ↗ “Alemtuzumab (MabCampath)” NCT00199030 ↗ |
| Action | Deplete | “Its administration temporarily depletes mature lymphocytes and some monocytes” NCT00001984 ↗ |
| Modality | Monoclonal antibody | “This protocol will test a humanized monoclonal antibody known as Campath-1H” NCT00001984 ↗ |
| Route | Intravenous | “Alemtuzumab was administered intravenously” NCT00001984 ↗ |
| Target | CD52 | “The humanized anti-CD52 monoclonal antibody alemtuzumab” PMID 19863336 ↗ Oct 2009 |