City of Hope (T Cell Manufacturing)

Duarte, CA

Profile last updated: 2026-03-21

National Center

CAR-T Cell Therapy

No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07

83.9

Signal Score

✓ FDA Inspections (3) ✓ Clinical Trials (215) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: City of Hope (T Cell Manufacturing)

Signal Score: 83.9/100 (as of 2026-09-07)
Quality Compliance: 97.1/100
Headquarters: Duarte, CA
Modalities: CAR-T, Cell Therapy
Active Programs: Data pending
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

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.

Quality Compliance

FDA Inspections3 on record

Warning Letters0

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

Operations

Programs — no verified data

Sponsors— no verified data

ModalitiesCAR-T, Cell Therapy

Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.

NCT07711327 Atrial Fibrillation Among Patients With Hematologic... NA Not Yet Recruiting

NCT07702578 A Study of T-Cell Receptor Engineered Donor T Cells in... PHASE3 Recruiting

NCT07227155 The HOPE Biobank Resource (BMT CTN 2402 HOPE) NA Recruiting

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 PHASE2 Withdrawn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 Active Not Recruiting

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

View all 215 programs →

Source: ClinicalTrials.gov · Retrieved Oct 06, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Capacity

Profile-based capacity assessment

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	Beckman Research Institute, City of Hope Duarte, California Company-level	Drug Quality Assurance	Yes	Voluntary Action Indicated (VAI)
2025-02-07	City Of Hope National Medical Center Duarte, California Facility-linked	Human Cellular, Tissue, and Gene Therapies	No	No Action Indicated (NAI)
2024-12-09	City of Hope National Medical Center Irvine, California Facility-linked	Blood and Blood Products	No	No Action Indicated (NAI)

Source: FDA Data Dashboard · Retrieved Oct 06, 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 215 studies

NCT07711327 Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine... NA Not Yet Recruiting NCT07702578 A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing... PHASE3 Recruiting NCT07227155 The HOPE Biobank Resource (BMT CTN 2402 HOPE) NA Recruiting NCT02943642 Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in... PHASE2 Withdrawn NCT07544589 A Phase 1 Study Evaluating DISP-10 in Participants With Advanced... PHASE1 Recruiting NCT07387367 A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus... PHASE3 Recruiting NCT07227415 Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404... PHASE1/PHASE2 Recruiting NCT07219212 A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in... PHASE1 Recruiting NCT07285694 AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration... PHASE1/PHASE2 Active Not Recruiting NCT04119024 Gene Modified Immune Cells After Conditioning Regimen for the Treatment of... PHASE1 Recruiting NCT04119024 Gene Modified Immune Cells After Conditioning Regimen for the Treatment of... PHASE1 Recruiting NCT06976736 A Long Term Follow-up Study of TScan TCR-T Products NA Recruiting NCT06859424 A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based... PHASE2 Recruiting NCT07075185 A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and... PHASE1 Recruiting NCT07038447 A Study of KITE-363 in Participants With Refractory Autoimmune Diseases PHASE1 Enrolling By Invitation NCT06552416 Safety of MT-401-OTS in Patients With Relapsed AML or MDS PHASE1 Recruiting NCT06533579 Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19) PHASE1/PHASE2 Recruiting NCT06657144 A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other... PHASE1 Recruiting NCT06805305 DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult... PHASE2 Recruiting NCT06528301 A Phase 1 Study of UB-VV111 With and Without Rapamycin in... PHASE1 Recruiting

+ 195 more studies

Source: ClinicalTrials.gov · Retrieved Oct 06, 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 215 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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