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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post infusion (syncar-001+stk-009)

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Cyclophosphamide

1995

Completed Phase 3

~3770

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this trial presently available for participants?

"The details on clinicaltrials.gov reflect that this medical trial is actively seeking participants. The research project was initially made available to the public on December 1st, 2022 and underwent its last alteration 16 days ago."

Answered by AI

To what degree can SYNCAR-001 + STK-009 be deemed hazardous?

"Since this is a Phase 1 trial and there is limited data surrounding safety and efficacy, the assessment of SYNCAR-001 + STK-009's security was rated as a score of one."

Answered by AI

How many participants are receiving treatment through this clinical investigation?

"Indeed, the information on clinicaltrials.gov suggests that this research is actively recruiting participants as of December 16th 2022. This trial was first posted on Dec 1st and they are currently looking to recruit 36 patients from a single medical centre."

Answered by AI

What are the aspirations of this experiment?

"The primary endpoint of this trial is the evaluation of adverse events over a period up to 28 days after administering SYNCAR-001+STK-009. Secondary endpoints include Duration of Response (DOR), Progression Free Survival (PFS) and Area under the Curve (AUC). DOR is used to evaluate long term anti-cancer response, PFS determines disease progression or death from any cause, whichever occurs earlier, while AUC quantifies cumulative drug levels over time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies

2022. "Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05665062.