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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.

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