C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma

NCT06210243 | Terminated Phase 1

• 1 other identifier: PH02001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed B cell non-Hodgkin lymphoma.

Conditions

Lymphoma, B-Cell; CAR-T

Outcome Measures

Primary Outcomes (2)

• The incidence and severity of adverse events (AEs)

  1 year

• Dose Limiting Toxicities

  First 28 days s after C752 injection

Secondary Outcomes (3)

• Objective response rate (ORR)

  1 year

• PFS

  1 year

• Pharmacokinetic - AUC

  1 year

Study Arms (1)

C752

EXPERIMENTAL

Biological: C752

Interventions

C752 BIOLOGICAL

C752 will be administered on Day 0

C752

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent in accordance with federal, local, and institutional guidelines, Males and females ≥18 years of age at the time of consent
• Documented diagnosis of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
• Have progression by least one systemic treatment and no available standard of care treatment.
• At least one measurable lesion by Lugano 2014
• Expected survival ≥ 12 weeks
• Have an ECOG performance status of 0 or 1
• Adequate organ function
• Screening test indicates histopathological CD19 + if the subject received CD19-targeted therapy
• Women of childbearing age must have a negative pregnancy test, and agree to take effective contraception during the trial

You may not qualify if:

• Treatment with any prior HSCT, gene therapy product, cell therapy product ect.
• Central nervous system involvement
• HBV/HCV
• HIV infection
• Concurrent use of systemic steroids or immunosuppression
• Uncontrolled active infection
• Wash-out period of from the last anti-cancer treatment
• Active second malignancy
• Have not recovered from the effects of previous therapy
• Have psychological or physical conditions that do not permit compliance with the protocol
• Pregnant or nursing (lactating) women

Sponsors & Collaborators

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China: lead
• Shanghai PerHum Therapeutics Co., Ltd.: collaborator

Study Sites (1)

920th Hospital of Joint LogisticsSupport Force of People's Liberation

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sanbin Wang, M.D.

  920th Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 18, 2024
• Study Start: December 24, 2023
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)