ALLO-329 RESOLUTION: three conditioning arms, first results
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ALLO-329 RESOLUTION: three conditioning arms, first results
Phase 1, off-the-shelf dual anti-CD19/anti-CD70 allogeneic CAR T. Data cutoff 21 September 2026.
No lymphodepletion
6 patients
20 million and 40 million cells, single dose
Cyclophosphamide alone
9 patients
20 million, 40 million and 80 million cells, single dose
Fludarabine + cyclophosphamide
3 patients
40 million cells, single dose
Safety, all 18 patients
No dose-limiting toxicities
No Grade 3+ cytokine release syndrome
No graft-versus-host disease
Skin score, 10 scleroderma patients
8 of 10 improved 5+ points on mRSS
4 reached a total score below 10
Preliminary, company-reported data from a small Phase 1 with no control arm. Results across arms are not a head-to-head comparison.
Cohort sizes, doses and results as reported by Allogene on November 9, 2026. M = million cells; mRSS = modified Rodnan skin score.
Some scleroderma patients improved on an off-the-shelf CAR T with no lymphodepleting chemotherapy at all.
Overall, 8 of 10 improved their skin scores by 5 points or more.
On November 9, 2026, Allogene Therapeutics reported preliminary Phase 1 data for ALLO-329, its dual anti-CD19/anti-CD70 allogeneic CAR T, in autoimmune disease. What matters for planning is the activity across three conditioning approaches, including none, not the 8 of 10. It is early, small and company-reported.
What Allogene reported
Allogene (Nasdaq: ALLO) announced preliminary safety, efficacy and translational data from its Phase 1 RESOLUTION study (NCT07085104) on November 9, 2026, with the data presented at ACR Convergence in Orlando. The data cutoff was September 21, 2026.
As of that date, 18 patients with systemic sclerosis (scleroderma), myositis or lupus had received a single dose of ALLO-329 and completed the 28-day dose-limiting toxicity period. The efficacy readout covers only 10 of them, the patients with skin-predominant scleroderma.
Eight of 10 skin-predominant scleroderma patients achieved and maintained a 5-point or greater improvement in skin score.
How ALLO-329 and the study are built
Allogene says ALLO-329 uses CRISPR-based site-specific integration for dual CAR expression, targeting both CD19-positive B cells and CD70-positive T cells. It also carries Allogene’s Dagger technology, designed to reduce or eliminate the need for conventional lymphodepletion.
The study tests that claim directly. RESOLUTION runs parallel dose escalation across three conditioning regimens: no lymphodepletion, cyclophosphamide alone, or fludarabine plus cyclophosphamide. Allogene says the design helps separate the effect of the cells from the effect of the chemotherapy, and aims to define the minimum lymphodepletion, if any, needed for meaningful activity.
The first 18 patients, by conditioning arm
- No lymphodepletion: 6 patients at 20 and 40 million cells (Allogene).
- Cyclophosphamide alone: 9 patients at 20, 40 and 80 million cells (Allogene).
- Fludarabine plus cyclophosphamide: 3 patients at 40 million cells (Allogene).
- Planned dose levels: five, from 20 million to 320 million cells; enrollment began in November 2025 (Allogene).
- Regulatory status: three FDA Fast Track designations granted in April 2025, for lupus, myositis and scleroderma (Allogene).
What the safety data show
Allogene reported no dose-limiting toxicities, no immune effector cell-associated hemophagocytic syndrome, no ICANS, no graft-versus-host disease and no Grade 3 or higher cytokine release syndrome. Cytokine release syndrome of any grade occurred in 4 of 18 patients (22%): three Grade 1 and one Grade 2.
Grade 3 or higher adverse events appeared in 3 of 18 patients (16.7%), all in the cyclophosphamide arm. Allogene says the no-lymphodepletion cohorts had no adverse event above Grade 2. Infections occurred in 3 of 18 patients, none Grade 3 or higher, and one patient (5.6%) had prolonged Grade 3 or higher cytopenia.
With 6 patients in the no-lymphodepletion arm, a clean safety record there is encouraging, not conclusive.
What the efficacy data show
In the 10 skin-predominant scleroderma patients, Allogene says skin score improvements appeared as early as Day 14 across all three dose levels and all lymphodepletion approaches, including none. Eight of 10 reached and maintained a 5-point or greater improvement in modified Rodnan skin score (mRSS), and several improved by 10 points or more. Four patients reached a total mRSS below 10.
Nine of 10 stayed off background immunosuppressive therapy, and the longest treatment-free interval is ongoing beyond 8 months. Allogene also describes one patient dosed with 40 million cells and no lymphodepletion. That patient’s disability index score (HAQ-DI) went from 1.63 to 0, and digital ulcers and tendon friction rubs resolved.
On the biology, B-cell suppression occurred in every arm and deepened with lymphodepletion intensity, while counts recovered fastest with none. Allogene notes that durable clinical improvement occurred without complete peripheral B-cell depletion.
What the data cannot tell you yet
GTC analysis: this is a single-arm study of 10 evaluable scleroderma patients, reported by the sponsor, with no control group. Follow-up is under a year, since enrollment began in November 2025. The arms are not a head-to-head comparison: the no-lymphodepletion arm had 6 patients across two dose levels, and the fludarabine plus cyclophosphamide arm had 3.
GTC analysis: one number would settle the conditioning question: how many of the 10 scleroderma patients were in the no-lymphodepletion arm. The release does not give it.
GTC analysis: the myositis and lupus patients are in the safety set but not in the efficacy readout. Allogene says those results, and data on two scleroderma patients who were not skin-predominant, are for future presentations. Nothing here says ALLO-329 works in lupus or myositis.
What this means for a CGT program
This is off-pillar CGT news under D-551: an allogeneic CAR T in autoimmune disease, not an AAV vector, platform, CDMO or IND decision. It can still be indexed on the website (D-555).
For seed and Series A AAV teams, start with Lock the Rights Before You Lock the Vector. See also the FDA Expedited IND Pilot and Catalent's IRO center of excellence.
Sourced fact: Allogene reports activity in scleroderma across very different conditioning approaches, including without lymphodepletion, and at the lowest cell doses studied. It says the next readout is planned for 2027.
GTC analysis (regulatory and protocol design): an allogeneic autoimmune program that locks fludarabine plus cyclophosphamide into its Phase 1 protocol by default may be spending its most informative design choice. A parallel-arm design that tests conditioning intensity, as RESOLUTION does, lets the sponsor show FDA which part of the regimen carries the benefit and which carries the risk. Whether FDA will accept that evidence for a given product is a question for a pre-IND discussion, not something this release answers.
GTC analysis (budget and vendor): if lymphodepletion can be reduced or dropped, treatment-site requirements change. Conditioning typically adds inpatient or monitored-infusion steps and site-activation burden, which feeds into trial-site selection and per-patient cost. What a no-lymphodepletion regimen would actually need on site is still open, so test this inference against your own protocol before it shapes site selection.
GTC analysis (CMC and timeline): low-dose activity matters for manufacturing. If an effective dose sits at the low end of 20 to 320 million cells, one lot could in principle treat more patients, which changes cost-of-goods and supply planning. Allogene has not shown that, and the Phase 2 regimen is still being selected, so no pivotal timeline should be planned around this readout before 2027.
If you have designed lymphodepletion strategy or early clinical protocols for allogeneic cell therapy, GTC’s Expert Network matches drug development experts like you to paid consulting work: join free.
Frequently asked questions
What did Allogene report for ALLO-329 in scleroderma?
On November 9, 2026, Allogene said 8 of 10 skin-predominant systemic sclerosis patients achieved and maintained a 5-point or greater improvement in modified Rodnan skin score (mRSS). Nine of 10 stayed off background immunosuppressive therapy. The data are preliminary, from the Phase 1 RESOLUTION study, with a data cutoff of September 21, 2026.
Does ALLO-329 need chemotherapy before dosing?
The study is testing three regimens: no lymphodepletion, cyclophosphamide alone, and fludarabine plus cyclophosphamide. Allogene reports clinical activity in scleroderma across all three, including no lymphodepletion. The company says the study is designed to define the minimum lymphodepletion, if any, needed for meaningful activity, so that question is still open.
How safe did ALLO-329 look in the first 18 patients?
Allogene reported no dose-limiting toxicities, no immune effector cell-associated hemophagocytic syndrome, no ICANS, no graft-versus-host disease and no Grade 3 or higher cytokine release syndrome. Cytokine release syndrome occurred in 4 of 18 patients (3 Grade 1, 1 Grade 2). Grade 3 or higher adverse events occurred in 3 of 18 patients, all in the cyclophosphamide arm.
How many patients does the efficacy result cover?
Ten. The skin-score result covers 10 skin-predominant systemic sclerosis patients. The 18-patient safety set also includes 4 myositis patients, 2 lupus patients and 2 scleroderma patients who were not skin-predominant. Allogene says those results are planned for future presentations.
When is the next ALLO-329 update?
Allogene says dose escalation continues and will inform the Phase 2 regimen. Five dose levels are planned, from 20 million to 320 million cells. The next data readout is planned for 2027.
Sources
- Allogene Therapeutics Reports First Clinical Data from the Phase 1 RESOLUTION Study of ALLO-329 - Allogene Therapeutics, press release via GLOBE NEWSWIRE, November 9, 2026. Source for every figure in this article: the 18-patient safety set, the three conditioning arms, the 10-patient skin score result, the translational findings, the Fast Track designations, the planned dose levels and the 2027 readout. A single, company-issued source; the ACR Convergence poster itself was not reviewed.
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