UnknownPhase 1

Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances

China20 participantsStarted 2020-12-01

Plain-language summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent; Patients volunteer to participate in the research
✓. Diagnosis is mainly based on the World Health Organization (WHO) 2008
✓. Patients have exhausted standard therapeutic options
✓. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
✓. Female must be not pregnant during the study

Exclusion criteria

✕. Patients declining to consent for treatment
✕. Prior solid organ transplantation
✕. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
✕. Any drug used for GVHD must be stopped \>1 week

What they're measuring

Dose limiting toxicity (DLT)

Timeframe: The first 28 days after infusion

Type of dose-limiting toxicity (DLT)

Timeframe: The first 28 days after infusion

Adverse event by severity

Timeframe: 2 years

Trial details

NCT IDNCT04934774

SponsoriCell Gene Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-01

Contact for this trial

Kevin Pinz, MS

6315386218 kevin.pinz@icellgene.com

View on ClinicalTrials.gov More T-cell Acute Lymphoblastic Leukemia trials