FDA Grants IND Clearance for ALLO-501, an Allogeneic CAR-T Candidate

Share this content:
Initiation of a phase 1 clinical trial of ALLO-501, an allogeneic CAR-T candidate, in patients with NHL is planned for early 2019.
Initiation of a phase 1 clinical trial of ALLO-501, an allogeneic CAR-T candidate, in patients with NHL is planned for early 2019.

The United States Food and Drug Administration (FDA) has granted investigational new drug (IND) clearance for ALLO-501, an allogeneic anti-CD19 monoclonal chimeric antigen receptor T-cell (CAR-T) therapy drug candidate developed by Allogene Therapeutics in collaboration with Servier Laboratories, to be evaluated in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).1

“Off-the-shelf” allogeneic CAR-T therapies derived from healthy donors are being investigated to potentially circumvent some of the recognized limitations of autologous CAR-T therapy, including potentially long wait periods for T cells to be collected and processed.2

In the upcoming phase 1 ALPHA trial, ALLO-501, designed to target CD19-positive malignancies, will be administered to up to 24 patients with the most common subtypes of NHL, relapsed/refractory diffuse large B-cell lymphoma or follicular lymphoma, following preconditioning chemotherapy with fludarabine/cyclophosphamide to deplete lymphocytes.

Patients will also receive pretreatment with ALLO-647, an investigational anti-CD52 monoclonal antibody (also manufactured by Allogene) that is thought to prevent host T cells expressing CD52 from rejecting ALLO-501.1  


  1. Allogene Therapeutics, in collaboration with Servier, announces FDA clearance of the IND for ALLO-501, an anti-CD19 allogeneic CAR T (AlloCAR T™) therapy. https://globenewswire.com/news-release/2019/01/28/1706115/0/en/Allogene-Therapeutics-in-Collaboration-with-Servier-Announces-FDA-Clearance-of-the-IND-for-ALLO-501-an-anti-CD19-Allogeneic-CAR-T-AlloCAR-T-Therapy.html. Published January 28, 2019. Accessed January 30, 2019.
  2. Graham C, Jozwik A, Pepper A, Benjamin R. Allogeneic CAR-T cells: more than ease of access? Cells. 2018;7(10):E155.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs