OUR PIPELINE
OUR AlloCAR T™ PIPELINE TARGETS A VAST ARRAY OF TUMOR TYPES
| Target | Program | Trial Name | Study Population | Discovery | IND-enabling | Phase 1 | Phase 21 | Approved | Designation | Next Milestone | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Hematologic Malignancies | CD19 |
ALLO-501A | ALPHA2 | 3+ Line LBCL |
|
FTD RMAT | Target enrollment completion 1H 2024 | ||||
CD19 |
ALLO-501A | ALPHA3 | 3+ Line LBCL |
|
Ph3 readiness in 2023 | ||||||
CD19 |
ALLO-501A + ALLO-6472 | EXPAND | 3+ Line LBCL |
|
Initiation activities underway | ||||||
CD19 |
CD19 - Next Generation |
|
|||||||||
BCMA |
ALLO-715 | UNIVERSAL | 5+ Line MM |
|
RMAT ODD | Preparing for Ph2 | |||||
BCMA |
ALLO-6053 | IGNITE | 5+ Line MM |
|
FTD ODD | Reviewing Process Improvements | |||||
CD70 |
ALLO-316 | Heme Malignancies |
|
||||||||
FLT3 |
ALLO-819 | AML |
|
||||||||
| Solid Tumors | CD70 |
ALLO-316 | TRAVERSE | ccRCC |
|
FTD | Cohort expansion 1H 2023 | ||||
CD70 |
ALLO-316 | Basket Study |
|
Determine histologies for inclusion | |||||||
DLL3 |
ALLO-213 | SCLC |
|
||||||||
Claudin 18.2 |
ALLO-182 | Gastric & Pancreatic Cancer |
|
||||||||
| 7 undisclosed targets |
|
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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.
The Phase 1 TRAVERSE Trial of ALLO-316 in Advanced Renal Cell Carcinoma (RCC)
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).
Episode 1: The TRAVERSE Study
Episode 2: The Dagger™ Technology Effect
Episode 3: Safety Profile of ALLO-316
Episode 4: TRAVERSE Case Studies
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-715: UNIVERSAL STUDY TARGETING B CELL MATURATION ANTIGEN (BCMA) IN RELAPSED/REFRACTORY (R/R)
MULTIPLE MYELOMA (MM)
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
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
- 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:
By phone
415-604-5696
By email
clinicaltrials@allogene.com
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.
