City of Hope (T Cell Manufacturing)

Duarte, CA

National Center

CAR-T Cell Therapy

210 confirmed programs · 132 sponsors · Last scored 2026-04-29

83.8

Signal Score

✓ FDA Inspections (3) ✓ Clinical Trials (210) ○ 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: 96.9/100
Headquarters: Duarte, CA
Modalities: CAR-T, Cell Therapy
Active Programs: 210 confirmed from ClinicalTrials.gov across 132 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

210 active programs across 132 sponsors · Modalities: Cell Therapy, CAR-T · 128 programs in advanced phases (Phase 2/3)

Programs 210

Sponsors132

ModalitiesCAR-T, Cell Therapy

210 active programs across 132 sponsors

Modalities: Cell Therapy, CAR-T

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 PHASE2 Withdrawn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 210 programs →

Source: ClinicalTrials.gov · Retrieved Jul 04, 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

City of Hope (T Cell Manufacturing) 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 Jul 04, 2026

City of Hope (T Cell Manufacturing) 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."

About this data →

Clinical Activity 210 studies

+ 190 more studies

Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Frequently Asked Questions About City of Hope (T Cell Manufacturing)

How many FDA inspections does City of Hope (T Cell Manufacturing) have on record?

CDMO Signal tracks 3 FDA inspections for City of Hope (T Cell Manufacturing), sourced from the FDA inspection database. See the full inspection history above.

Has City of Hope (T Cell Manufacturing) received an FDA warning letter?

CDMO Signal has no FDA warning letters on record for City of Hope (T Cell Manufacturing).

How many clinical programs is City of Hope (T Cell Manufacturing) linked to?

City of Hope (T Cell Manufacturing) is associated with 210 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.

What is City of Hope (T Cell Manufacturing)'s CDMO Signal Score?

City of Hope (T Cell Manufacturing) has a Signal Score of 84/100, based on quality, operations, financial stability, and capacity data.

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