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C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma

T

The 920th Hospital of The Joint Logistics Support Force of the Chinese People's Liberation Army

Status and phase

Enrolling
Phase 1

Conditions

Lymphoma, B-Cell
CAR-T

Treatments

Biological: C752

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06210243
PH02001

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

C752
Experimental group
Treatment:
Biological: C752

Trial contacts and locations

1

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Central trial contact

Rang Gao, M.D.; Sanbin Wang, M.D.

Data sourced from clinicaltrials.gov

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