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CAR T-cell Therapy

CAR-T Cell Therapy + IL-2 for Blood Cancer

Phase 1
Recruiting
Research Sponsored by Synthekine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post infusion (syncar-001+stk-009)
Awards & highlights

Study Summary

This trial tests a new treatment for blood cancer in humans for the first time. #medicalresearch

Who is the study for?
This trial is for people with certain blood cancers like lymphoma or leukemia that have come back or didn't respond to treatment. They must have cancer cells likely to carry CD19, no brain disease symptoms, and can't have had recent bone marrow transplants or previous CD19-targeted therapies.Check my eligibility
What is being tested?
The study tests a new therapy combining SYNCAR-001 (a type of CAR-T cell therapy) with STK-009 (an IL-2 treatment), alongside standard drugs Cyclophosphamide and Fludarabine. It's the first time this combination is being tried in humans.See study design
What are the potential side effects?
CAR-T therapies like SYNCAR-001 can cause flu-like symptoms, difficulty breathing, low blood pressure, confusion, seizures, organ inflammation and may lead to severe immune reactions. The other drugs may also contribute similar side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post infusion (syncar-001+stk-009)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post infusion (syncar-001+stk-009) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Area under the curve (AUC)
Duration of Response (DOR)
Immunogenicity
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SYNCAR-001 + STK-009 Cohort BExperimental Treatment2 Interventions
Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with repeated sequential ascending doses of STK-009 subcutaneously (SC) Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with repeated doses of STK-009 SC at the RP2D
Group II: SYNCAR-001 + STK-009 Cohort AExperimental Treatment4 Interventions
Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with repeated sequential ascending doses of STK-009 subcutaneously (SC) Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with repeated doses of STK-009 SC at the RP2D
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1020
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

SynthekineLead Sponsor
1 Previous Clinical Trials
202 Total Patients Enrolled

Media Library

SYNCAR-001 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05665062 — Phase 1
Mantle Cell Lymphoma Research Study Groups: SYNCAR-001 + STK-009 Cohort A, SYNCAR-001 + STK-009 Cohort B
Mantle Cell Lymphoma Clinical Trial 2023: SYNCAR-001 Highlights & Side Effects. Trial Name: NCT05665062 — Phase 1
SYNCAR-001 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05665062 — Phase 1
~18 spots leftby Jun 2026
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