🧬 CAR-T Cell Manufacturing Initiation Assessment Recommendation Form

Patient ID: Diagnosis: Apheresis Date: Assessment Date: Planned Infusion Date:

Domain	Assessment Item	Feb 25 — Re-evaluation (Manufacturing Decision Point)	Dynamic Comparison Criteria & Decision Standards	Weight
I CNS-Specific (Core Focus)	Brain MRI with Contrast Lesion · Edema · Mass Effect		If explosive lesion progression, new acute cerebral edema, or significantly worsened mass effect → manufacturing prohibited. Lesions must be stable or shrinking.	HOLD
	CSF Analysis Pressure · Protein · Cell Count · Flow Cytometry		If CSF malignant cells not cleared, or protein/cell count surges dramatically vs. baseline → indicates extremely high ICANS risk.	HIGH
	Neurological Function ICE / MMSE		If score significantly declines vs. baseline, suggests pre-existing CNS damage — proceed with extreme caution.	HIGH
II Bridging & Washout (Timing Control)	BsAb Washout Washout Period Management		Counting back from planned infusion date, must allow adequate washout period (typically ≥5 half-lives). If unachievable → delay or halt.	HIGH
	Post-BsAb Response Assessment Imaging · Molecular · Target Expression		Evaluate disease control status post-BsAb bridging & impact on CAR-T: ① Imaging Response (Lugano Criteria) · CR/PR → Tumor burden reduced; CRS risk relatively manageable post-infusion · SD → Disease stabilized; may still proceed · PD (Progressive Disease) → Caution: uncontrolled tumor burden increases risk of severe CRS/TLS post-infusion; however, if no other treatment options, PD is not an absolute contraindication ② Target Antigen Expression Changes · Post-BsAb (especially CD20×CD3), monitor for potential target antigen downregulation/loss · If CAR-T and BsAb share the same target antigen (e.g., both targeting CD19), assess whether bridging has selected for antigen-negative clones · If CAR-T targets a different antigen from the BsAb, impact is minimal ③ CNS-Specific Assessment · Cross-reference with brain MRI: assess CNS lesion response to BsAb · BsAb has limited CNS penetration; intracranial lesions may respond independently of systemic disease	HIGH
	Radiation Therapy (RT) Progress & BBB Recovery		For cranial RT: allow adequate BBB integrity recovery period (typically ≥2 weeks) from RT completion to infusion, to mitigate risk of radiation-induced BBB permeability increase leading to excessive CAR-T CNS infiltration and severe ICANS.	HIGH
III Bone Marrow · Immunity · Infection (Safety Baseline)	Occult Infection Screening Pathogen Workup		If new, uncontrolled active infection is identified (especially fungal or viral) → manufacturing prohibited.	HOLD
	Bone Marrow Function HEMATOTOX WBC · ANC · Hgb · PLT + CAR-HEMATOTOX	📐 CAR-HEMATOTOX Score Calculator ANC Hgb PLT CRP Ferritin Please complete all 5 items above	CAR-HEMATOTOX Score (0–5): · 0–1 = Low risk: hematologic toxicity expected to be manageable · ≥2 = High risk: significantly elevated risk of severe/prolonged cytopenias post-lymphodepletion; increased risk of neutropenic infections & bleeding Also monitor trends: ANC declined >50% from baseline or <0.5×10⁹/L; PLT <50×10⁹/L → high risk of intracranial hemorrhage in CNS patients; Hgb <70 g/L transfusion-dependent. If severe pancytopenia with no recovery trend + CAR-HEMATOTOX ≥3, carefully assess lymphodepletion tolerability.	MID
	Lymphocytes & T-Cell Subsets ALC · CD3⁺ · CD4⁺ · CD8⁺ · CD4/CD8		⚠️ Apheresis is complete; this assesses patient immune reserve (not cell product quality). · ALC declined >70% from baseline or <0.3×10⁹/L → immune reserve depletion · CD4⁺ <200/μL → severe immunodeficiency-like state; extremely high opportunistic infection risk · CD4/CD8 ratio severely inverted (<0.3) or acutely worsening → ICANS risk signal · Treg proportion elevated vs. baseline → may suppress in vivo CAR-T expansion · PD-1⁺/TIM-3⁺/LAG-3⁺ proportion significantly elevated → severe T-cell exhaustion	HIGH
	Coagulation PT · APTT · FIB · D-dimer		Coagulation abnormalities in CNS patients → extremely high intracranial hemorrhage risk. · PT/APTT significantly prolonged, FIB <1.5 g/L → DIC risk during CRS · D-dimer elevated several-fold → hypercoagulability or disease progression signal	MID
IV Organ · Performance · Complications (Tolerance)	Performance Status (ECOG) Functional Status Score		If ECOG drops precipitously (e.g., 1 → >2), patient unlikely to survive CRS period → manufacturing not recommended.	HOLD
	Core Organ Function Cardiac · Hepatic · Renal		Ensure bridging has not caused irreversible organ damage: LVEF ≥45%　AST/ALT ≤2.5×ULN　CrCl ≥45 mL/min	HOLD
	Tumor Burden & Inflammation LDH · Ferritin · CRP/IL-6		If LDH and ferritin show exponential surge vs. baseline, suggests rapid disease progression or hyperinflammatory state → extremely high risk of severe CRS post-infusion.	MID
	High-Risk Complication Warning IL-6 · Albumin · CMV/EBV		Three categories of correctable but critical high-risk warnings: ① IL-6 Baseline Inflammation · IL-6 markedly elevated vs. baseline (>10× reference) → higher CRS starting point, faster progression, more likely to develop ≥Grade 3 CRS · Determine whether inflammation is driven by active infection vs. tumor itself ② Hypoalbuminemia · Albumin <30 g/L → capillary leak syndrome risk ↑↑; fluid management during CRS will be difficult · Albumin <25 g/L → severe nutritional depletion; overall tolerance extremely poor ③ CMV/EBV Latent Viruses · CMV DNA positive or rising copy number → high risk of fulminant reactivation post-lymphodepletion; CMV pneumonitis/retinitis carries significant mortality · EBV DNA positive and rising → may lead to EBV-associated lymphoproliferative disease in the immunodeficient state	HIGH

📊 Integrated Decision Dashboard

Decision Logic (14 Items Total):
① Any HOLD weight item 🔴 Not Met → Direct HOLD Manufacturing
② All HOLD items Met, but HIGH weight items have 🔴 ≥1 or 🟡 ≥3 → Conditional GO
③ Only MID weight items with Watch/Not Met → GO (with monitoring plan)
④ All 🟢 → GO

Assessed

/ 14 items

🟢 Met

items

🟡 Watch

items

🔴 Not Met

items

HOLD Triggered

items

⏳ Please Complete All Assessments

Select a judgment for each item to auto-generate the decision recommendation

✅ GO Action Checklist:

Notify manufacturing facility to officially initiate CAR-T production
Confirm BsAb washout back-calculation timeline → lock LD chemotherapy & infusion calendar
Establish high-risk ICANS protocol (CNS patients); reserve ICU bed & neurology consultation
Develop pre-infusion immune support plan addressing T-cell subset abnormalities
For CAR-HEMATOTOX high-risk: pre-arrange blood products, G-CSF protocol, extended monitoring
For high-risk complication warning items flagged: actively correct during manufacturing period (albumin supplementation, antiviral therapy, inflammation control)
Prepare tocilizumab, dexamethasone, and other CRS/ICANS rescue medications

⚠️ Conditional GO Action Checklist:

Explicitly list all 🟡/🔴 items; discuss countermeasures item-by-item with attending physician
May initiate manufacturing to save time; set re-assessment checkpoint before infusion
If PD after BsAb bridging: evaluate tumor proliferation rate; develop pre-infusion debulking plan
If T-cell subset abnormalities: assess need for pre-infusion immunomodulatory intervention
If CAR-HEMATOTOX ≥2: develop hematologic toxicity-specific management plan
If IL-6/albumin/CMV/EBV abnormal: use the 3–4 week manufacturing window to correct; set target thresholds
Schedule re-evaluation at 3–5 days; define improvement targets for each item

🛑 HOLD Action Checklist:

Clearly communicate to physician which specific items failed and why
Continue/adjust bridging therapy to address the conditions triggering HOLD
Schedule re-assessment in 1–2 weeks; define mandatory hard targets for clearance
Confirm cryopreserved apheresis product storage conditions and viability timeline
If severe marrow/immune suppression: evaluate G-CSF or immune support therapy
Correct reversible factors: pre-emptive antiviral therapy, nutritional support, albumin infusion

This assessment form is an internal Medical Affairs decision-support tool and does not replace clinical judgment.
Final decisions must incorporate prescribing information, clinical guidelines, and attending physician input.
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