This section highlights FDA-related milestones and regulatory updates for drugs developed by Allogene Therapeutics (ALLO).
Over the past two years, Allogene Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALLO-316, ALLO-329, and Cemacabtagene. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ALLO-316 - FDA Regulatory Timeline and Events
ALLO-316 is a drug developed by Allogene Therapeutics for the following indication: Advanced or Metastatic Renal Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALLO-316
- Announced Date:
- June 1, 2025
- Indication:
- Advanced or Metastatic Renal Cell Carcinoma
Announcement
Allogene Therapeutics, Inc. presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma (RCC) during an oral presentation at the 2025 ASCO Annual Meeting.
AI Summary
Allogene Therapeutics, Inc. recently presented updated data from its Phase 1 TRAVERSE study of ALLO-316, a CAR T therapy for advanced renal cell carcinoma (RCC), at the 2025 ASCO Annual Meeting. In the trial, a single dose of ALLO-316 led to a 31% confirmed response rate among patients with high levels of CD70. Most responders maintained their benefit, with one patient experiencing remission for over 12 months.
The study demonstrated that ALLO-316 expanded quickly, persisted in the body, and effectively infiltrated tumors using a standard lymphodepletion regimen with cyclophosphamide and fludarabine. Safety results were manageable thanks to proactive measures in controlling side effects. These encouraging findings highlight the potential of ALLO-316 to reduce tumor burden and offer new hope for patients with advanced RCC who have exhausted other treatment options.
Read Announcement- Drug:
- ALLO-316
- Announced Date:
- May 22, 2025
- Indication:
- Advanced or Metastatic Renal Cell Carcinoma
Announcement
Allogene Therapeutics, Inc. announced the publication of two abstracts on the American Society of Clinical Oncology (ASCO) website in advance of the 2025 ASCO Annual Meeting, taking place May 30-June 3 in Chicago, Illinois.
AI Summary
Allogene Therapeutics announced that it has published two new abstracts on the ASCO website ahead of the 2025 ASCO Annual Meeting in Chicago, Illinois, which will be held from May 30 to June 3. One abstract features an oral presentation on ALLO-316, an investigational AlloCAR T product that targets CD70 and is being explored for advanced or metastatic clear cell renal cell carcinoma.
The presentation will include updated data from the Phase 1 TRAVERSE study, focusing on patient treatment using a standard regimen of cyclophosphamide and fludarabine followed by one dose of 80 million CAR T cells. The other abstract is a Trial-in-Progress poster detailing the design of the ongoing pivotal Phase 2 ALPHA3 trial, which evaluates cemacabtagene ansegedleucel as part of a first-line consolidation strategy in patients with large B-cell lymphoma who are minimal residual disease positive.
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ALLO-329 - FDA Regulatory Timeline and Events
ALLO-329 is a drug developed by Allogene Therapeutics for the following indication: For the Treatment of Autoimmune Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALLO-329
- Announced Date:
- April 7, 2025
- Indication:
- For the Treatment of Autoimmune Diseases
Announcement
Allogene Therapeutics, Inc announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA)
AI Summary
Allogene Therapeutics, Inc. announced that its investigational therapy, ALLO-329, has received three Fast Track Designations from the U.S. Food and Drug Administration (FDA). ALLO-329 is a dual-targeted CD19/CD70 allogeneic CAR T cell therapy aimed at treating serious autoimmune diseases. The Fast Track Designations were granted for the treatment of adult patients with active refractory moderate-to-severe systemic lupus erythematosus (SLE), severe or refractory idiopathic inflammatory myopathy (IIM), and active refractory diffuse systemic sclerosis (SSc). These designations highlight the FDA’s recognition of the potential for ALLO-329 to address significant unmet medical needs in autoimmune care. The therapy utilizes innovative CRISPR gene-editing techniques and the company’s proprietary Dagger® technology, which may help reduce or eliminate the need for lymphodepletion. Allogene plans to start its Phase 1 RESOLUTION basket trial in mid-2025 to further evaluate the product's safety and early effectiveness.
Read Announcement- Drug:
- ALLO-329
- Announced Date:
- January 28, 2025
- Indication:
- For the Treatment of Autoimmune Diseases
Announcement
Allogene Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a rheumatology basket study of ALLO-329, an investigational allogeneic CAR T product.
AI Summary
Allogene Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALLO-329, an investigational allogeneic CAR T product. This clearance allows the company to move forward with a Phase 1 RESOLUTION rheumatology basket trial focused on evaluating safety and early signs of effectiveness in treating autoimmune diseases. The trial will include patients with systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis.
A key feature of this study is the use of Allogene’s innovative Dagger® technology. This approach is designed to boost CAR T cell expansion while preventing immune rejection, potentially reducing or eliminating the need for traditional lymphodepletion. The trial, set to begin in mid-2025, marks an important step toward transforming treatment options for patients with autoimmune disorders.
Read Announcement- Drug:
- ALLO-329
- Announced Date:
- November 18, 2024
- Indication:
- For the Treatment of Autoimmune Diseases
Announcement
Allogene Therapeutics, Inc announced preclinical data for ALLO-329, an investigational allogeneic CD19/CD70 dual CAR T cell therapy being evaluated as a treatment for autoimmune diseases.
AI Summary
Allogene Therapeutics, Inc. has presented promising preclinical data for ALLO-329, an investigational allogeneic CAR T cell therapy for autoimmune diseases. ALLO-329 is unique because it targets both CD19+ B cells and CD70+ activated T cells, which may help reset the immune system more effectively than therapies that focus on one cell type. The dual targeting is designed to induce deep, though transient, depletion of the problematic immune cells and reduce levels of IgG and IgM antibodies without requiring traditional lymphodepleting chemotherapy.
The therapy utilizes Allogene’s proprietary Dagger® technology to overcome rejection by eliminating alloreactive T cells, which could improve the persistence of the CAR T cells in the patient. These findings support the potential for ALLO-329 to address a broader spectrum of autoimmune dysfunction, and the company plans to file an IND with the FDA in the first quarter of 2025.
Read Announcement- Drug:
- ALLO-329
- Announced Date:
- September 26, 2024
- Indication:
- For the Treatment of Autoimmune Diseases
Announcement
Allogene Therapeutics announced that it will present pre-clinical data for its next-generation investigational AlloCAR T candidate for autoimmune indications, ALLO-329, at the American College of Rheumatology's annual meeting, ACR Convergence 2024, being held from November 14-19 in Washington, D.C.
AI Summary
Allogene Therapeutics announced it will present pre-clinical data for its next-generation investigational AlloCAR T candidate, ALLO-329, at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, in Washington, D.C., from November 14-19. ALLO-329 is designed for autoimmune indications and features a dual-target approach that focuses on CD19+ B cells and CD70+ activated T cells. This dual targeting aims to address both B-cell and T-cell dysfunction commonly seen in autoimmune diseases. The investigational product uses a CRISPR-based gene editing platform for precise, site-specific integration, which is intended to reduce the potential risk of secondary malignancies. Additionally, ALLO-329 incorporates Allogene’s patented Dagger® technology. This innovative feature could minimize or even eliminate the need for lymphodepletion, a significant hurdle in the wider adoption of CAR T therapies for autoimmune conditions.
Read Announcement
Cemacabtagene Ansegedleucel - FDA Regulatory Timeline and Events
Cemacabtagene Ansegedleucel is a drug developed by Allogene Therapeutics for the following indication: For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cemacabtagene Ansegedleucel
- Announced Date:
- February 13, 2025
- Indication:
- For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse
Announcement
Allogene Therapeutics, Inc. announced the publication of data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501/A) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) as a Rapid Communication in the Journal of Clinical Oncology.
AI Summary
Allogene Therapeutics, Inc. announced that data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel), previously known as ALLO-501/A, has been published as a Rapid Communication in the Journal of Clinical Oncology. The study focused on patients with relapsed/refractory large B-cell lymphoma (LBCL) and represents the largest dataset for an allogeneic CAR T cell product in this group. With a two-year follow-up period, the trials demonstrated that cema-cel could achieve durable complete remissions and an overall response rate similar to approved autologous CD19 CAR T therapies. The findings show promise for off-the-shelf CAR T therapy and support further research, including the ongoing ALPHA3 trial, which will test cema-cel as a consolidation therapy for patients at high risk of relapse. The results mark a significant milestone in improving treatment options for LBCL patients.
Read Announcement- Drug:
- Cemacabtagene Ansegedleucel
- Announced Date:
- June 20, 2024
- Estimated Event Date Range:
- January 1, 2026 - June 30, 2026
- Target Action Date:
- H1 2026
- Indication:
- For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse
Announcement
Allogene Therapeutics Inc announced that ALPHA3 Expected to Complete Enrollment in 1H 2026
AI Summary
Allogene Therapeutics Inc. recently announced that the Phase 2 ALPHA3 trial is expected to complete patient enrollment in the first half of 2026. The study is designed to evaluate cemacabtagene ansegedleucel (cema-cel) as a one-time, off-the-shelf treatment provided as a “7th cycle” after patients complete six standard cycles of chemoimmunotherapy for large B cell lymphoma (LBCL). The trial will use Foresight Diagnostics’ CLARITY™ test to screen for minimal residual disease (MRD) in patients likely to relapse, allowing for early intervention. Additionally, the study will be conducted across various cancer centers, including community sites where many LBCL patients are treated. Efficacy analyses, including event free survival comparisons, are planned during 2026 with a potential biologics license application submission targeted for 2027.
Read Announcement- Drug:
- Cemacabtagene Ansegedleucel
- Announced Date:
- June 20, 2024
- Indication:
- For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse
Announcement
Allogene Therapeutics Inc announced that BLA Submission Anticipated in 2027
AI Summary
Allogene Therapeutics recently announced progress in its pivotal Phase 2 ALPHA3 trial for treating newly diagnosed large B cell lymphoma (LBCL). The study evaluates the use of their off-the-shelf CAR T cell therapy, cemacabtagene ansegedleucel (cema-cel), as a bridging treatment for patients who show minimal residual disease after standard chemoimmunotherapy. Approximately 240 patients at various cancer centers will be enrolled, with the aim of improving event-free survival and overall cure rates by administering cema-cel as a "7th cycle" following six cycles of traditional treatment.
Importantly, with efficacy analyses planned for 2026, Allogene anticipates submitting a Biologics License Application (BLA) in 2027. This anticipated BLA submission marks a key step towards potentially securing regulatory approval and making this innovative CAR T therapy available in community settings for patients at risk of relapse.
Read Announcement- Drug:
- Cemacabtagene Ansegedleucel
- Announced Date:
- June 20, 2024
- Indication:
- For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse
Announcement
Allogene Therapeutics Inc announced the initiation of the pivotal Phase 2 ALPHA3 trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) treatment regimen for newly diagnosed LBCL patients who are likely to relapse after standard 1L treatment and need further therapy.
AI Summary
Allogene Therapeutics Inc. has announced the start of its pivotal Phase 2 ALPHA3 trial. This study will evaluate the use of cemacabtagene ansegedleucel (cema-cel) in the first line (1L) treatment for newly diagnosed large B-cell lymphoma (LBCL) patients who are at high risk of relapse after standard therapy. The trial uses the Foresight Diagnostics’ CLARITY™ test to detect minimal residual disease (MRD) following six cycles of conventional chemoimmunotherapy, such as R-CHOP. Once MRD is detected, eligible patients will receive a single infusion of cema-cel as a “7th cycle” consolidation treatment aimed at improving cure rates.
This study could offer a new therapeutic option that makes an off-the-shelf CAR T cell treatment accessible in community cancer centers, potentially delivering an important alternative for patients who might relapse after initial treatment.
Read Announcement
