City of Hope (T Cell Manufacturing)

Duarte, CA

National Center

CAR-T Cell Therapy

209 confirmed programs · 131 sponsors · Last scored 2026-04-29

83.8

Signal Score

✓ FDA Inspections (3) ✓ Clinical Trials (209) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: City of Hope (T Cell Manufacturing)

Signal Score: 83.8/100 (as of 2026-04-29)
Quality Compliance: 96.8/100
Headquarters: Duarte, CA
Modalities: CAR-T, Cell Therapy
Active Programs: 209 confirmed from ClinicalTrials.gov across 131 sponsors
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About City of Hope (T Cell Manufacturing)

CDMO.

Signal Score & Pillar Breakdown

Quality Compliance

FDA Inspections3 on record

Warning Letters0

Last InspectionVoluntary Action Indicated (VAI) (2025-08-20)

Operations

209 active programs across 131 sponsors · Modalities: CAR-T, Cell Therapy · 128 programs in advanced phases (Phase 2/3)

Programs 209

Sponsors131

ModalitiesCAR-T, Cell Therapy

209 active programs across 131 sponsors

Modalities: CAR-T, Cell Therapy

128 programs in advanced phases (Phase 2/3)

Source: ClinicalTrials.gov facility matching

NCT02943642 Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion... PHASE2 Withdrawn

NCT07544589 A Phase 1 Study Evaluating DISP-10 in Participants With... PHASE1 Recruiting

NCT07387367 A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment... PHASE3 Recruiting

NCT07227415 Symbiotic-GU-08: A Study to Learn About the Medicine Called... PHASE1/PHASE2 Recruiting

NCT07219212 A Study of JNJ-90301900 in Combination With Chemoradiation... PHASE1 Recruiting

NCT07285694 AB-3028, a Programmable Circuit T Cell Therapy in Patients... PHASE1/PHASE2 Recruiting

NCT04119024 Gene Modified Immune Cells After Conditioning Regimen for the... PHASE1 Recruiting

NCT06976736 A Long Term Follow-up Study of TScan TCR-T Products NA Recruiting

NCT06859424 A Platform Protocol to Investigate Post-Transplant... PHASE2 Recruiting

View all 209 programs →

Source: ClinicalTrials.gov · Retrieved May 20, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Parent company: City of Hope

Financial assessment: 68.0/100

Capacity

1 manufacturing site

1 manufacturing site: Duarte, CA

Modalities: CAR-T, Cell Therapy

Capacity assessment: 58.0/100

FDA Inspection History

2025-08

2025-02

2024-12

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-08-20	Duarte, California	Drug Quality Assurance	Yes	Voluntary Action Indicated (VAI)
2025-02-07	Duarte, California	Human Cellular, Tissue, and Gene Therapies	No	No Action Indicated (NAI)
2024-12-09	Irvine, California	Blood and Blood Products	No	No Action Indicated (NAI)

Source: FDA Data Dashboard · Retrieved May 20, 2026

FDA 483 Findings 3 observations · 2025-08-20 → 2025-08-20 ?

By subsystem

Laboratory Controls 2 (66.7%)
Documentation & Records 1 (33.3%)

By severity

3 — Moderate: 2
2 — Minor: 1
Repeat observations: 0

Most severe findings

Moderate (3) Laboratory Controls 2025-08-20 21 CFR 211.194(a)(2)

Suitability of testing methods verified

"The suitability of all testing methods is not verified under actual conditions of use."
Moderate (3) Laboratory Controls 2025-08-20 21 CFR 211.160(b)

Scientifically sound laboratory controls

"Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components conform to appropriate standards of identity, strength, quality and purity."
Minor (2) Documentation & Records 2025-08-20 21 CFR 211.22(d)

Procedures not in writing, fully followed

"The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed."