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CAR T-cell Therapy

UCART22 for Acute Lymphoblastic Leukemia

Phase 1

Recruiting

Led By Nitin Jain, MD

Research Sponsored by Cellectis S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

B-ALL blast cells expressing CD22

Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment for leukemia, UCART22, to see if it is safe and effective. They will be giving it to patients intravenously and will be monitoring for side effects and how well it works.

Who is the study for?

This trial is for people with B-cell acute lymphoblastic leukemia (B-ALL) that has come back or didn't respond to treatment. They must have tried at least one standard chemo and one more intense rescue therapy. Patients who've had cell or gene therapies in the last 60 days can't join.Check my eligibility

What is being tested?

The study tests UCART22, a new therapy given through the veins, on patients with relapsed/refractory B-ALL. It aims to find out how safe it is, its effects on leukemia, and the best dose for future studies.See study design

What are the potential side effects?

Possible side effects of UCART22 may include reactions related to infusion, changes in blood counts, increased risk of infections, fever, fatigue, and potential impact on normal bone marrow function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia cells test positive for CD22.

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I have undergone at least one initial and one follow-up chemotherapy treatment.

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I have relapsed or refractory B-cell acute lymphoblastic leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)

Incidence of AE/SAE/DLT [Safety and Tolerability]

Secondary outcome measures

Duration of Response

Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)

Overall Survival

+2 more

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT01395316

13%

Hypothyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Alemtuzumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment2 Interventions

Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART22 administered at the RP2D

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cellectis S.A.Lead Sponsor

5 Previous Clinical Trials

157 Total Patients Enrolled

Nitin Jain, MDPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

1,647 Total Patients Enrolled

Media Library

UCART22 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04150497 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: Dose Escalation

Acute Lymphoblastic Leukemia Clinical Trial 2023: UCART22 Highlights & Side Effects. Trial Name: NCT04150497 — Phase 1

UCART22 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150497 — Phase 1

Frequently Asked Questions

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

How many participants are being welcomed into this experiment?

"Cellectis S.A., the trial sponsor, will be running this study from two sites located in Philadelphia and Chicago respectively. In order to receive accurate results, 40 qualified participants are necessary for the experiment's completion."

Answered by AI

What qualifications must a participant possess in order to be considered for this trial?

"This medical research is seeking 40 participants with leukemia, lymphocytic, acute L1 between the age range of 15-70. The applicants must display certain characteristics including B-ALL blast cells expressing CD22, a previous diagnosis of R/R B-ALL and successful completion at least one chemo and salvage therapy regimen."

Answered by AI

Are there multiple facilities conducting the research in America?

"This clinical trial is currently running at 6 medical centres, which are located in Philadelphia, Chicago and Houston, alongside other locales. To minimize travel requirements for those enrolling, it can be beneficial to select the nearest available location."

Answered by AI

Does this research initiative cater to individuals younger than twenty years of age?

"Patients that are 15 to 70 years old can join this clinical trial."

Answered by AI

Does UCART22 pose any potential health risks to patients?

"As this is a Phase 1 trial, and therefore has limited data backing its efficacy or safety, our team at Power estimates that UCART22's security should be considered level 1 on the scale of risk."

Answered by AI

Are participants currently being accepted for this research endeavor?

"Per the information hosted on clinicaltrials.gov, recruitment is actively underway for this trial which was first advertised on October 14th 2019 and has been recently amended as of September 23rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

2019. "Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04150497.

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