Allogene公布ALLO-316肾癌Phase 1完整数据的JCO论文发表，核心31% ORR数据此前已在ASCO 2025披露

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Allogene Therapeutics Announces Journal of Clinical Oncology Publication of Phase 1 Results of ALLO-316 Highlighting First Durable Remissions Following Allogeneic CAR T for Treatment of Metastatic Solid Tumors

Jul 15, 2026 at 8:30 AM EDT

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ALLO-316 Achieved a 31% Confirmed Response Rate with the Recommended Phase 2 Regimen in Patients with Stage IV Renal Cell Carcinoma (RCC) with High CD70 Expression
Single Dose of ALLO-316 Produced Durable Responses in this Cohort with All Responders Progression-Free at the Time of Analysis

Responses Range from 8 to 18+ Months, with Median Overall Survival Not Yet Reached

Safety Profile was Manageable with Proactive Diagnostic and Management Strategies Effective in Mitigating IEC-HS

ALLO-316 Demonstrated Robust Expansion and Tumor Infiltration Following Standard Lymphodepletion, Validating the Dagger ® Technology as a Next-Generation Allogeneic CAR T Platform

SOUTH SAN FRANCISCO, Calif. , July 15, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics , Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced the publication of complete Phase 1 data from the TRAVERSE study of ALLO-316 in advanced or metastatic renal cell carcinoma (RCC) in the Journal of Clinical Oncology . TRAVERSE is being conducted as part of a strategic five-year collaboration with The University of Texas MD Anderson Cancer Center . ALLO-316, Allogene’s CD70-targeting AlloCAR T investigational therapy incorporating the Dagger ® technology, achieved robust expansion, tumor infiltration, and durable antitumor activity in a solid tumor setting.

“TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field,” said Zachary Roberts , M.D., Ph.D., President and Chief Executive Officer of Allogene. “CAR T has transformed hematologic malignancies while solid tumors have remained one of the field’s most difficult challenges. When we designed ALLO-316 with the Dagger ® technology, our goal was to address two of the most persistent barriers in solid tumors – achieving robust CAR T expansion with standard lymphodepletion and translating that biology into durable responses. These results show that a well-designed allogeneic CAR T product, developed for a defined population, can expand, persist, and produce durable responses in metastatic, treatment refractory solid tumors. Importantly, the robust CAR T expansion and durable persistence in this trial provides clinical validation of our Dagger ® technology platform and has direct read-through to our broader clinical and preclinical pipeline of next-generation AlloCAR T candidates.”

Across the full Phase 1 TRAVERSE trial, 51 patients with Stage IV disease were enrolled, of whom 46 received ALLO-316 and had a median follow-up time of 28.8 months. The Phase 1b expansion cohort evaluated the safety and efficacy of the recommended Phase 2 regimen – ALLO-316 at a dose of 80M CAR T cells following a standard FC lymphodepletion regimen (fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) for 3 days). The 22 patients in the Phase 1b safety population all had RCC resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor (TKI), 82% had received ≥2 prior TKIs, and 41% had received prior belzutifan. Twenty of these patients received ALLO-316. Sixteen of the ALLO-316-treated patients in Phase 1b had a high CD70 Tumor Proportion Score (TPS ≥50%). The median time from enrollment to the start of therapy was four days.

“Most patients in TRAVERSE had exhausted available therapies and faced a poor prognosis, with survival often measured in months,” said Samer A. Srour, MB ChB, MS, of The University of Texas MD Anderson Cancer Center . “In that context, the depth and durability of responses observed with a one-time ALLO-316 infusion are very promising, particularly in patients with high CD70-expressing tumors where all responders remained progression-free at the time of the published analysis. Taken together, these findings strongly support the continued clinical development of ALLO-316 and its evaluation as a potential new treatment approach for patients with advanced RCC.”

A single dose of ALLO-316 produced disease control in half of patients in the Phase 1b cohort, with an overall confirmed response rate of 25% and a confirmed response rate of 31% in patients with CD70 TPS ≥50%. The median duration of response (mDOR) had not been reached (95% CI: 6.9 months to not estimable), with the longest ongoing response exceeding 18 months. Median overall survival in the Phase 1b population was 15.2 months (95% CI: 4.6 months to not estimable) and was not estimable in the CD70-high group (95% CI: 3.2 months to not estimable).

CD70+ patients Phase 1b (N=20)
n (%)

ORR (confirmed CR or PR per RECIST v1.1)
5/20 (25%)

CD70 TPS ≥50%
5/16 (31%)

CD70 TPS <50%
0/4 (0)

RECIST v1.1, Response Evaluation Criteria in Solid Tumors, version 1.1; TPS, tumor proportion score

The safety profile of ALLO-316 was manageable and consistent with lymphodepletion and an active CAR T product across the full Phase 1 trial. The most frequent Grade ≥3 events were hematologic. Three previously reported treatment related Grade 5 adverse events occurred in the Phase 1a portion (cardiogenic shock, failure to thrive and sepsis). There were no Grade 5 adverse events in Phase 1b. A higher incidence of IEC-HS was reported in Phase 1b relative to Phase 1a, likely due in part to improved diagnosis and coding implemented during Phase 1b. Most IEC-HS events were mild to moderate and were successfully managed utilizing a protocol-defined diagnostic and management algorithm.

TEAEs ≥20% incidence
Phase 1b (N=22*)
n (%)

Any Grades
Grade ≥3

Neutropenia
18 (82%)
18 (82%)

White blood cell count decreased
16 (73%)
16 (73%)

Anemia
13 (59%)
9 (41%)

Fatigue
5 (23%)
0

Nausea
8 (36%)
0

Thrombocytopenia
13 (59%)
7 (32%)

Pyrexia
8 (36%)
0

Peripheral edema
8 (36%)
0

ALT increased
7 (32%)
2 (9%)

Headache
5 (23%)
0

Arthralgia
8 (36%)
0

AST increased
6 (27%)
2 (9%)

Lymphopenia
5 (23%)
5 (23%)

AEs of Special Interest
Any Grade
Grade ≥3

CRS
15 (68%)
0

Infection
11 (50%)
9 (41%)

IEC-HS
8 (36%)
2 (9%)ᵃ

ICANS
4 (18%)
0

Graft-versus-host disease
0
0

* Two patients received lymphodepletion but did not receive ALLO-316: one due to progression of disease (altered mental status during lymphodepletion found to be brain metastases on imaging), and one due to liver and kidney failure during lymphodepletion. IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis.
ᵃ One patient experienced Grade 4 IEC-HS based on gastrointestinal bleeding with subsequent improvement; one patient experienced Grade 3 IEC-HS based on hypotension managed without vasopressors with subsequent improvement.

The findings also underscore the broader strategic potential of the Dagger ® technology, which addresses rejection by the patient’s immune system. By targeting CD70-expressing tumor cells as well as CD70-positive alloreactive host T cells, ALLO-316 is designed to support CAR T-cell expansion and persistence without requiring intensified lymphodepletion. In TRAVERSE, this design translated into robust expansion, durable persistence, and evidence of tumor infiltration – core attributes Allogene believes may be applicable across its next-generation clinical and pre-clinical allogeneic CAR T pipeline.

About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate