CD147-CAR T Cells for Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

NCT05013372 | Unknown Early Phase 1

• 1 other identifier: CD147-CAR T for R/R T-NHL
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.

Conditions

T-cell Non-Hodgkin's Lymphoma

Keywords

CAR T cells; T-cell Non-Hodgkin's lymphoma; CD147

Outcome Measures

Primary Outcomes (5)

• Maximum tolerated dose (MTD)

  The highest dose that does not cause unacceptable side effects.

  within 12 months

• Dose-limiting toxicity (DLT)

  Side effects serious enough to prevent an increase in dose.

  within 12 months

• Adverse events

  Adverse events

  within 12 months

• Serious adverse events (SAE)

  Serious adverse events (SAE)

  within 12 months

• Adverse events of special interest (AESI)

  within 12 months

Secondary Outcomes (6)

• Overall response rate (ORR)

  At the 12th week, 6th month, 9th month and 12th month

• Complete response rate (CR)

  At the 12th week, 6th month, 9th month and 12th month

• Duration of response (DOR)

  At the 12th week, 6th month, 9th month and 12th month

• Cmax of CD147-CAR T cells

  within 4 weeks

• Tmax of CD147-CAR T cells

  within 4 weeks

Study Arms (1)

Dose-escalation

OTHER

Dose -1：0.1×10E+6/kg Dose 1：0.25×10E+6/kg Dose 2：0.5×10E+6/kg Dose 3：1.0×10E+6/kg Dose 4：2.0×10E+6/kg

Drug: CD147- CAR T cells

Interventions

CD147- CAR T cells DRUG

CAR T cells targeting CD147

Also known as: CAR T cells targeting CD147

Dose-escalation

Eligibility Criteria

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

You may qualify if:

• The subject must meet all of the following criteria:
• years old;
• Relapsed or refractory T-NHLs, including peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), ALK-positive ALCL, ALK-negative Image result for anaplastic large cell lymphoma (ALCL), enteropathy-related T-cell lymphoma, hepatosplenic T-cell lymphoma, etc.;
• Previously received ≥2 lines of treatment without a complete response;
• Immunohistochemical detection of tumor cells CD147 positive;
• ECOG score 0-2;
• The collection of mononuclear cells can be performed upon the judgment of the researcher;
• No contraindications for allogeneic hematopoietic stem cell transplantation (AlloHCT);
• Have donors for AlloHCT;
• Agree for sequential treatment of AlloHCT;
• Without serious organ dysfunction in 2 weeks before CAR-T infusion:
• Heart: without arrhythmia, LVEF≥50%, and without pericardial effusion; without heart failure (NYHA class III or IV) within12 months before CAR-T infusion; without myocardial infarction within 12 months before CAR-T infusion; without long-QT syndrome or secondary QT interval prolongation;
• Liver: ALT\<2 times the upper limit of normal (ULN) and TBIL\<1.5 times ULN, without active hepatitis;
• APTT and PT\<1.5 times ULN;
• Kidney: Serum creatinine \<1.5 mg/dl; or if the serum creatinine exceeds the upper limit, eGFR (CKD-EPI formula) needs to be \> 50 ml/min;

You may not qualify if:

• Anyone who has one or more of the following:
• A history of other malignancies with a disease-free period \< 5 years (except for cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
• Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation;
• Patients with bone marrow involvement;
• Those who are allergic to the biological agents in CAR-T cell product ;
• Pregnant or breastfeeding;
• Active bacterial, fungal or viral infection;
• Receiving systemic hormone therapy 1 week before participating in the clinical trial;
• Have received other gene therapy before;
• HBV or HCV infection or carrier is defined as: HBsAg positive or HBV-DNA positive; anti-HCV positive and HCV-RNA positive;
• Active HIV infection;
• Clinical diagnosis of virus infection or uncontrolled virus activation, including cytomegalovirus (CMV), adenovirus (ADV), BK virus or human herpesvirus 6 (HHV-6), etc.;
• Central nervous system lymphoma (CNSL) is defined as the presence of ≥5 tumor cells/ ul in cerebrospinal fluid (CSF) or MRI suggested CNSL; any other CNS diseases, such as uncontrolled epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease involving the central nervous system, or received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatments);
• Imaging determined lung infection;
• Inappropriate to participate in the trial with investigators' decision.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Lymphoma, T-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

• Xiaojun Huang, MD. PhD.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenmiao Yang, MD.

CONTACT

13439999810; yangshenmiao@hotmail.com

Xiaojun Huang, MD. PhD.

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share