OUR AlloCAR T™ PIPELINE TARGETS A VAST ARRAY OF TUMOR TYPES

Target Program Trial Study Population Discovery IND-enabling Phase 1 Phase 21 Approved Designation Next Milestone
HEMATOLOGIC MALIGNANCIES
CD19
(Key Program)
cema-cel
(ALLO-501A)
ALPHA3
1L Consolidation LBCL
Start-up activivities initiated
CD19
cema-cel ALPHA2 3L LBCL FTD RMAT Enrolling
CD19
cema-cel + ALLO-6472 EXPAND 3L LBCL FTD
(ALLO-647)
Enrolling
CD19
(Key Program)
cema-cel
ALPHA2
r/r CLL
Trial initiation Q1 2024
BCMA
ALLO-715 UNIVERSAL 5+ Line MM RMAT ODD Reviewing manufacturing process
BCMA
ALLO-6053 IGNITE 5+ Line MM FTD ODD Reviewing manufacturing process
CD70
ALLO-316 Various
FLT3
ALLO-819 AML
SOLID TUMORS
CD70
(Key Program)
ALLO-316
TRAVERSE
ccRCC
FTD
Cohort expansion 2024
CD70
ALLO-316 Other Solid
DLL3
ALLO-213 SCLC
Claudin 18.2
ALLO-182 Gastric & Pancreatic
AUTOIMMUNE DISEASE
CD19/
CD70
(Key Program)
ALLO-329
Lupus/SLE
Trial initiation 1H 2025
Category Target Program Trial Study Population Stage Designation Next Milestone
Hematologic Malignancies CD19
(Key Program)
cema-cel
(ALLO-501A)
ALPHA3 1L Consolidation LBCL Phase 2 Start-up activities initiated
Hematologic Malignancies CD19 cema-cel ALPHA2 3L LBCL Phase 2 FTD RMAT Enrolling
Hematologic Malignancies CD19 cema-cel + ALLO-6472 EXPAND 3L LBCL Phase 2 FTD (ALLO-647) Enrolling
Hematologic Malignancies CD19
(Key Program)
cema-cel ALPHA 2 r/r CLL Phase 1 Trial initiation Q1 2024
Hematologic Malignancies BCMA ALLO-715 UNIVERSAL 5+ Line MM Phase 1 RMAT ODD Reviewing manufacturing improvements
Hematologic Malignancies BCMA ALLO-6053 IGNITE 5+ Line MM Phase 1 FTD ODD Reviewing manufacturing improvements
Hematologic Malignancies CD70 ALLO-316 Heme Malignancies IND-ENABLING
Hematologic Malignancies FLT3 ALLO-819 AML Discovery
Solid Tumors CD70 (Key Program) ALLO-316 TRAVERSE ccRCC Phase 1 FTD Cohort expansion 2024
Solid Tumors CD70 ALLO-316 Other Solid IND-ENABLING
Solid Tumors DLL3 ALLO-213 SCLC IND-ENABLING
Solid Tumors Claudin 18.2 ALLO-182 Gastric & Pancreatic IND-ENABLING
Autoimmune Disease CD19/CD70 (Key Program) ALLO-329 Lupus/SLE IND-ENABLING Trial initiation 1H 2025

¹Phase 3 may not be required if Phase 2 is registrational
²ALLO-647 (anti-CD52 mAb) is intended to enable expansion and persistence of allogeneic CAR T product candidates
³TurboCARTM

DATABRIEF

The DataBrief video series highlights the latest clinical findings from our investigational allogeneic CAR T cell (AlloCAR T™) products.

ALPHA/ALPHA 2

ASCO 2023 – Allogene presented long-term follow up data from the Phase 1 ALPHA/ALPHA2 trials of ALLO‑501/501A demonstrating for the first time the potential of allogeneic CD19 CAR T to induce durable complete remissions in relapsed/refractory large B-cell lymphoma (r/r LBCL) at a rate similar to approved autologous CD19 CAR T therapies.

TRAVERSE

AACR 2023 – We presented early findings from the Phase 1 TRAVERSE trial evaluating the safety, tolerability, and activity of ALLO-316, an investigational AlloCAR T™ product candidate for the treatment of CD70 positive advanced or metastatic clear cell renal cell carcinoma (RCC).

The Industry's First Allogeneic CAR T Phase 2 Trial: ALLO-501A ALPHA2 Phase 2 Study TARGETING CD19 IN RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA

Allo 501A
Timeline_for_Allogene 501A

ALLO-715: UNIVERSAL STUDY TARGETING B CELL MATURATION ANTIGEN (BCMA) IN RELAPSED/REFRACTORY (R/R)
MULTIPLE MYELOMA (MM)

B Cell Maturation Antigen
ALLO-715 UNIVERSAL Study Overview

Primary Objective:

  • Safety and tolerability

Key Secondary Objectives:

  • Recommended ALLO-715 Phase 2 dose and lymphodepletion regimen
  • Anti-tumor activity (ORR, duration of response, PFS, and MRD)
  • ALLO-715 cellular kinetics (blood levels of anti-BCMA CAR T cells)
  • ALLO-647 pharmacokinetics (serum ALLO-647 concentrations)

ALLO-605: IGNITE STUDY UTILIZING FIRST TurboCAR™ TO TARGET BCMA

  • TurboCAR™ is designed to recapitulate cytokine signaling selectively in CAR T
    • Does not stimulate host immune cells which could cause systemic toxicity or reject CAR
    • Delivers survival benefit selectively to CAR T cells
  • Opportunities for development include improving the efficacy of CAR T cells
ALLO-605 Ignite Study Overview
Primary Endpoints (Phase 1):

  • Safety and tolerability of ALLO-605
Secondary Endpoints (Phase 1):

  • Anti-tumor activity and cellular kinetics of ALLO-605
  • ALLO-647 pharmacokinetics
  • Evaluate immunogenicity against ALLO-605 and ALLO-647
  • Evaluate responses in subjects with previous treatment with an anti-BCMA targeted therapy
Safety Assessment

ALLO-316: INVESTIGATING AN AlloCAR T™ IN RENAL CELL CARCINOMA

ALLO-316 is an anti CD70 AlloCAR T™ candidate for renal cell carcinoma (RCC) as well as several hematological malignancies

CD70 target selectively expressed in several cancers1:

  • RCC (80-100% of tumors)
    • High prevalence with limited ‘off tumor’ expression

Phase 1 TRAVERSE trial in RCC initiated in 1H 2021

  • ALLO-316 is associated with minimal or no fratricide
  • Study endpoints
    • Primary endpoints: Safety and tolerability
    • Secondary endpoints: Anti-tumor efficacy, PK/PD
Safety Assessment
  1. Expert Opin Ther Targets. 2008 Mar; 12(3): 341–351. doi: 10.1517/14728222.12.3.341

CLINICAL TRIALS

Allogene is committed to the development of AlloCAR T™ products for cancer. Successful clinical trials are required to gain regulatory approval for new medications to advance patient care and may be required to support any approved products.

 

A list of existing Allogene clinical trials is below. For more information on Allogene clinical trials that may be recruiting, search Allogene at www.clinicaltrials.gov

PROGRAM PHASE INDICATION
ALLO-501A 2 The ALPHA2 Trial: Relapsed or refractory non-Hodgkin lymphoma (NHL)
ALLO-501A/ALLO-647 2 The EXPAND Trial: Relapsed or refractory non-Hodgkin lymphoma (NHL)
ALLO-715 1 The UNIVERSAL Trial: Relapsed or refractory multiple myeloma (MM)
ALLO-316 1 TRAVERSE Study: Renal Cell Carcinoma
ALLO-605 1 The IGNITE Study: Relapsed or refractory multiple myeloma (MM)

ALLOGENE’S EXPANDED ACCESS POLICY

“Expanded Access” refers to the use of an investigational product outside of a clinical trial for potential treatment of a serious or life-threatening condition. Allogene Therapeutics is developing allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for patients with blood and solid tumors. Consistent with our commitment to bring innovative, safe, and effective products to patients, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our products broadly available as quickly and safely as possible. Participation in one of our clinical trials is the best and preferred route to access these investigational products. Allogene does not currently have any active Expanded Access protocols nor do we currently provide access to our investigational products on an Expanded Access basis. We encourage patients interested in our investigational products to learn more about our ongoing studies by visiting clinicaltrials.gov.

 

Treating physicians may request information about Allogene’s Expanded Access policy by contacting our clinical trials team:

Allogene will respond to inquiries within 5 business days from receipt.

In the event Allogene decides to consider making one or more of its investigational candidates available for patients who have a serious or life-threatening condition through an Expanded Access program, general criteria to be considered may include: availability of alternative products, the potential risks and benefits to the patient, adequate supply, and potential interference with Allogene’s ongoing clinical trials. All requests would be evaluated on a case-by-case basis in a fair and equitable manner.

This policy shall not serve as a guarantee of access to any specific investigational candidates by any individual patient. Allogene reviews its policies from time to time to ensure conformity with applicable laws and regulations. We reserve the right to revise this policy at any time.

SCIENTIFIC PUBLICATIONS

CD19

December 2023

Cellular Mechanisms Affecting Allogeneic CAR T Cell Expansion and Rejection in Large B-cell Lymphoma*

*In collaboration with The University of Texas MD Anderson Cancer Center.

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June 2023

Presentation, Durable Responses Achieved with Anti-CD19 Allogeneic CAR T ALLO-501/501A in Phase 1 Trials of Autologous CAR T-Naïve Patients with Relapsed/Refractory Large B-Cell Lymphoma (r/r LBCL)

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June 2023

Poster, Durable Responses Achieved with Anti-CD19 Allogeneic CAR T ALLO-501/501A in Phase 1 Trials of Autologous CAR T-Naïve Patients with Relapsed/Refractory Large B-Cell Lymphoma (r/r LBCL)

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June 2023

Poster, Phase 1 Results with Anti-CD19 Allogeneic CAR T ALLO-501/501A in Relapsed/Refractory Large B-Cell Lymphoma (r/r LBCL)

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June 2023

Presentation, Phase 1 Results with Anti-CD19 Allogeneic CAR T ALLO-501/501A in Relapsed/Refractory Large B-Cell Lymphoma (r/r LBCL)

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ALPHA Study

December 2021

ALPHA Study: ALLO-501 Produced Deep and Durable Responses in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma, Comparable to Autologous CAR

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ALPHA2 Study

December 2021

ALPHA2 Study: ALLO-501A Allogeneic CAR T in LBCL, Updated Results Continue to Show Encouraging Safety and Efficacy with Consolidation Dosing

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First In Human Data of Allo 501A

June 2021

First-In-Human Data of ALLO-501A, An Allogeneic Chimeric Antigen Receptor (CAR) T Cell Therapy, and ALLO-647 in Relapsed/Refractory Large B Cell Lymphoma (R/R LBCL): ALPHA2 Study

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First In Human Data of Allo 501

May 2020

American Society of Clinical Oncology (ASCO) May 2020 – First-in-Human Data of ALLO-501 and ALLO-647 in Relapsed/Refractory Large B-cell or Follicular Lymphoma (R/R LBCL/FL): ALPHA Study

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ALPHA2 Study

December 2018

American Society of Hematology (ASH) Dec. 2018 — UCART19 PALL and CALM Studies

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BCMA

August 2023

Constitutive Turbodomains Enhance Expansion and Antitumor Activity of Allogeneic BCMA CAR T Cells in Preclinical Models

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January 2023

Allogeneic BCMA-Targeting CAR T Cells in Relapsed/Refractory Multiple Myeloma: Phase 1 UNIVERSAL Trial Interim Results

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December 2022

Poster, UNIVERSAL Updated Phase 1 Data Highlight Role of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma

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December 2022

Presentation, UNIVERSAL Updated Phase 1 Data Highlight Role of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma

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March 2022

Allogeneic Anti-BCMA CAR T Cells Are Superior to Multiple Myeloma-derived CAR T Cells in Preclinical Studies and May Be Combined with Gamma Secretase Inhibitors

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UNIVERSAL Updated Phase 1 Data Validates the Feasibility of Allogeneic

December 2021

UNIVERSAL Updated Phase 1 Data Validates the Feasibility of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma

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Preclinical Evaluation of ALLO 605

December 2020

Preclinical Evaluation of ALLO-605, an Allogeneic BCMA TurboCAR T™ Cell Therapy for the Treatment of Multiple Myeloma

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First In Human Data of Allo 715

December 2020

First-in-Human Study of the Allogeneic Anti-BCMA ALLO-715 CAR T cell Therapy and the Anti-CD52 Mab ALLO-647 in Relapsed/Refractory Multiple Myeloma (UNIVERSAL Study)

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American Society of Hermatology

December 2019

American Society of Hematology (ASH) Dec. 2019 – Allogeneic Anti-BCMA CAR T Cells Show Tumor Specific Killing Against Primary Multiple Myeloma Cells

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CD70

April 2023

TRAVERSE: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 in Patients with Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

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April 2022

Preclinical Development and Evaluation of Allogeneic CAR T Cells Targeting CD70 for the Treatment of Renal Cell Carcinoma

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April 2022

Preclinical Development and Evaluation of Allogeneic CAR T Cells Targeting CD70 for the Treatment of Renal Cell Carcinoma

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Investigation of ALLO-316

December 2020

Investigation of ALLO-316: A Fratricide-Resistant Allogeneic CAR T Targeting CD70 As a Potential Therapy for the Treatment of AML

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American Association for Cancer Research

April 2019

American Association for Cancer Research (AACR) April 2019 – AlloCAR T™ Targeting CD70 For RCC

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FLT3

Allogeneic FLT3 CAR T Cells

October 2020

Allogeneic FLT3 CAR T Cells with an Off-Switch Exhibit Potent Activity against AML and Can Be Depleted to Expedite Bone Marrow Recovery

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Preclinical Evaluation of ALLO-819

December 2019

American Society of Hematology (ASH) Dec. 2019 – Preclinical Evaluation of ALLO-819, Targeting FLT3, in Acute Myeloid Leukemia

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ALLO-819

December 2018

American Society of Hematology (ASH) Dec. 2018 – ALLO-819, An Allogeneic FLT3 CAR T Therapy Possessing An Off-Switch for the Treatment of Acute Myeloid Leukemia

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DLL3

January 2023

Allogeneic CAR T Cells Targeting DLL3 Are Efficacious and Safe in Preclinical Models of Small Cell Lung Cancer

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June 2020 Screening and Characterization of AlloCAR T Targeting

June 2020

American Association for Cancer Research (AACR) June 2020 – Screening and Characterization of AlloCAR T™ Targeting DLL3 for the Treatment of Small Cell Lung Cancer

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CLAUDIN18.2

November 2023

Preclinical Development and Characterization of Allogeneic CAR T Cells Targeting Claudin18.2 Positive Tumors

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ALLO-647

December 2023

ALLO‑647 for Lymphodepletion in the Allogeneic CAR T Cell Setting: Safety Experience With ALLO‑501‌ /‌ 501A in Patients With Relapsed / Refractory Large B-Cell and Follicular Lymphomas

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Safety and PK/PD of ALLO-647

June 2021

Safety and PK/PD of ALLO-647, an Anti-CD52 Antibody, With Fludarabine (Flu)/Cyclophosphamide (Cy) for Lymphodepletion in Allogeneic CAR T Cell Therapy

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PLATFORM

November 2023

Preclinical Evaluation of Allogeneic CD19 CAR T Cells Expressing an Anti-Rejection CD70 CAR

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November 2023

Generation of Immune-Evasive Allogeneic CAR T Cells by Inactivation of the HLA Transcriptional Regulator RFX5 and Disruption of the Immune Synapse

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February 2023

Selective Targeting of Host CD70+ Alloreactive Cells With a CD70 Dagger™ Receptor to Prolong Allogeneic CAR T Cell Persistence

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November 2022

Generation of Hypoimmunogenic Allogeneic CAR T Cells by Inactivation of Transcriptional Regulators of HLA Class I and II Genes

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May 2022

Allogeneic CAR T Cells Derived From Younger Donor T Cells Have More Desirable T Cell Phenotype And Better in vitro Functionality

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PD1 TurboCAR T Cells

April 2021

PD1 TurboCAR™ T Cells: PD1-Resistant CAR T Cells With Programmable Cytokine Signaling Outputs

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June 2020 SMIC CAR T Cells

June 2020

American Association for Cancer Research (AACR) June 2020 – SMIC CAR T Cells: CAR T with Temporally-Controlled, Programmable Cytokine Signaling Outputs

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May 2020 TurboCAR T Cells

May 2020

American Society of Gene and Cell Therapy (ASGCT) May 2020 – TurboCAR™ T Cells: CAR T Cells with Constitutive, Programmable Cytokine Signaling Outputs

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Off the Shelf Allogeneic CAR T Cells

April 2020

Toward “Off-the-Shelf” Allogeneic CAR T Cells

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Safeguards for Chimeric Antigen Receptor T-Cell

June 2018

A Versatile Safeguard for Chimeric Antigen Receptor T-Cell Immunotherapies Valton J, Guyot V, Boldajipour B, et al.

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