GoFast™ CAR-T on MARS® Atlas
Rapid manufacturing, preclinical potency, and early clinical signal in refractory MG – Case study
This case study summarizes the GoFast™ workflow on MARS® Atlas, preclinical potency in a CD19+ xenograft model, and early clinical observations in three patients with severe, refractory myasthenia gravis.
GoFast™ workflow: rapid CAR-T process
No expansion:
Maintain T cell stemness and naiveness
High potency:
More potent than traditional CAR-T
Simple & fast:
Isolation → Transduction → Purification, 2x cell handlings
Low cost potential:
• Effective with <30M CAR-T cells per dose
• Start from ~100mL PB or 20mL LP, 0.5B ~ 2B total cells
• Manufacture cost could be < $10K
Removing access barriers to CAR-T therapies
GoFast™ workflow on MARS® Atlas dramatically reduces the cost, time, labor, depreciation, and operational burden of CAR-T manufacturing—removing key access barriers and enabling broader patient access.
| Traditional | MARS GoFast | |
|---|---|---|
|
Cost |
$50k–$150K |
< $10K |
|
Time |
3–4 weeks |
<3 days |
|
System setup |
Limited |
Scalable |
|
CAR-T Dose |
100s Million |
1s~10s Million |
MARS® Atlas enables an automated, <72h workflow
MARS® Atlas integrates T-cell selection, activation/transduction, and harvest in a closed, streamlined process. It is designed to support rapid CAR-T manufacturing in less than 72 hours while maintaining T-cell stemness for in vivo persistence. The platform is intended to simplify manufacturing and support scalable, cost-effective processing from fresh or washed leukopak input.
GoFastTM rapid manufacture preserves key CAR-T product attributes
Following CD4/CD8 selection, GoFastTM CAR-T products achieved greater than 90% CD3+ purity while maintaining a preferable CD4/CD8 ratio.
Transduction efficiency averaged approximately 79% CAR+ across the product, and activation markers CD25 and CD69 were expressed in about 50% of cells, indicating robust activation.
The resulting cells exhibited a high proportion of less differentiated, stem-like phenotypes with elevated CD45RA+/CCR7+ populations, reflecting a favorable, durable cell profile.
Key takeaways
- >90% CD3+ purity after selection
- ~79% CAR+ transduction efficiency
- >50% CD25+/CD69+ activated cells
- High CD45RA+/CCR7+ population
Lower-dose GoFastTM CAR-T outperformed higher-dose traditional CAR-T in vivo
In a CD19+ NALM6 xenograft model, GoFastTM CAR-T achieved strong and sustained tumor control at one-fifth the administered cell dose.
At the lower dose, GoFastTM CAR-T cells produced significantly greater tumor suppression than traditional CAR-T, with 4 × 10⁵ GoFastTM cells outperforming 2 × 10⁶ traditional CAR-T cells.
This represents an approximately 80% lower administered cell dose in this model. Across all cohorts, treated mice maintained stable body weight with no evident systemic toxicity.
The study evaluated multiple doses, monitored CAR-T expansion, and assessed tolerability to demonstrate the balance of efficacy and safety.
Key takeaways
- 80% lower GoFastTM CAR-T dose showed stronger tumor suppression
- 4 × 10⁵ GoFastTM vs. 2 × 10⁶ traditional CAR-T cells/mouse
- Sustained in vivo tumor control supports preserved functional potency
- Stable body weight across cohorts
Clinical study design
1.
Patient Screening
(6 patient / 28 days)
2.
Pre-Treatment Evaluation / Leukapheresis
(5 days)
3.
CAR-T Cell Manufacturing
(Traditional 14-20 days / GoFast 3 days)
GoFast CAR-T Manufacture MARS Atlas (3 days)
4.
Lymphodepletion Chemotherapy
(5 days before infusion)
5.
Core Treatment and Evaluation
(D0~W12)
Dose: 1E5 CART/kg (GoFast CAR-T)
6.
Follow-up period
(12–24 weeks)
7.
Extended observation period
(24 to 52 weeks)
GoFast™ CAR-T manufacturing on the MARS® Atlas platform was completed in approximately 3 days. This was followed by about 3 additional days for sterility testing and quality control release, resulting in a total manufacture-to-release workflow of approximately 6 days.
Patients received lymphodepletion chemotherapy 5 days before infusion. GoFastTM CAR-T was administered at 1 × 10⁵ cells/kg. Core evaluation included safety, DLTs, vital signs, and efficacy endpoints through Week 12, with extended safety and efficacy follow-up through Week 52.
Key takeaways
- 3-day GoFastTM CAR-T manufacturing on MARS Atlas
- 6 days from manufacturing through QC release
- 1 × 10⁵ CAR-T cells/kg administered
- Core evaluation through Week 12
- Extended safety and efficacy follow-up through Week 52
Early clinical observations
Complete depletion of CD19+ B cells was observed by Day 7 and maintained throughout the period of observation, indicating sustained target engagement.
GoFastTM CAR-T expanded rapidly, with peak expansion reaching approximately 2,200 copies/μL around Day 14. Expansion then followed the expected pharmacodynamic pattern, with a gradual decline through Day 28.
Together, these findings demonstrate early and robust biological activity consistent with the expected pharmacologic profile of GoFastTM CAR-T.
Key takeaways
- Complete CD19+ B-cell depletion by Day 7
- ~2,200 copies/μL peak CAR-T expansion
- Peak expansion around Day 14
CD19+ B-cell depletion by Day 7
CAR-T expansion peaked at approx. 2,200 copies/µL around Day 14
GoFastTM CAR-T showed a manageable early safety and inflammatory profile
In the first-patient observation, the safety profile was consistent with expectations for CAR-T therapy.
Grade 3–4 lymphocytopenia was observed as anticipated with lymphodepletion, and mild changes in other blood counts were transient and clinically manageable.
No serious treatment-related events were reported during the core evaluation period. Cytokine assessments demonstrated low-level, transient fluctuations without a persistent hyperinflammatory pattern.
Key takeaways
- No serious adverse events reported
- Transient hematologic changes
- Low-level cytokine fluctuations
- No persistent hyperinflammation
GoFastTM CAR-T produced rapid and sustained improvement in MG disease scores
Clinically meaningful responses were achieved rapidly in both QMG and MG-ADL.
Patient 1 demonstrated a sharp improvement by Day 14, surpassing predefined thresholds for both measures.
These responses were sustained throughout the available follow-up period, indicating durable clinical benefit.
Improvements in QMG and MG-ADL supported a consistent and meaningful clinical response.
Key takeaways
- QMG and MG-ADL response thresholds exceeded by Day 14
- Deep improvement across both disease-score measures
- Response sustained through follow-up
- Rapid onset of clinical benefit in Patient 1
GoFastTM CAR-T reached Minimal Symptom Expression by Day 14
MG-ADL declined to the Minimal Symptom Expression (MSE) range by Day 14 and was maintained through the follow-up period.
When compared with historical data from conventional-process cohorts, MSE was reached approximately around Day 90–180.
These results suggest a faster onset of response with GoFastTM CAR-T in this first-patient observation.
The contextual comparison is presented to illustrate potential advantages in time to response with the GoFastTM platform.
Key takeaways
- MSE reached by Day 14
- Rapid MG-ADL improvement
- Earlier response than the contextual conventional-process cohort
- Single-patient observation; 6-patient cohort ongoing
GoFastTM rapid workflow summary
Closed, automated workflow on MARS Atlas
Preserved CAR-T product attributes and functional persistence
Stronger preclinical performance at lower administered dose in the mouse model
Early first-patient MG signal supports continued evaluation
Estimated GoFastTM CAR-T Essential Kit COGs: ~$9,500 per patient
Cross-study clinical comparisons are contextual only and are not from head-to-head studies.
For Research Use Only. Not for use in clinical, diagnostic, or therapeutic procedures.
