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CAR T-cell Therapy

UCART22 for Acute Lymphoblastic Leukemia

Phase 1 & 2

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

Must not have

Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't had any cell or gene therapy in the last 60 days.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT01395316

13%

Hypothyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Alemtuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met