NCT05168748

Brief Summary

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous chimeric antigen receptor (CAR) T cells targeting both CD19 and CD22, manufactured with T-Charge(TM) process. CAR-T cells will be investigated as single agent in pediatric and adult acute lymphoblastic leukemia (ALL).

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
2mo left

Started Jan 2023

Typical duration for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2023Aug 2026

First Submitted

Initial submission to the registry

November 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2026

Last Updated

December 21, 2022

Status Verified

September 1, 2022

Enrollment Period

3.6 years

First QC Date

November 3, 2021

Last Update Submit

December 20, 2022

Conditions

Acute Lymphoblastic Leukemia

Keywords

CAR-TIMJ995CD19CD22acute lymphoblastic leukemia (ALL)pediatricadolescent

Outcome Measures

Primary Outcomes (3)

  • Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only, in pediatric, adolescent and young adult ALL patients)

    Dose recommendation for IMJ995 in pediatric, adolescent and young adult ALL patients

    28 days

  • Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (pediatric, adolescent and young adult ALL patients)

    Safety and tolerability

    24 months

  • Number of patients infused with planned target dose

    Manufacture success rate

    24 months

Secondary Outcomes (8)

  • Incidence and nature of DLTs during the first 28 days after IMJ995 infusion (safety cohort for adult ALL).

    28 days

  • Cellular kinetics of IMJ995 (maximum drug concentration - Cmax)

    24 months

  • Cellular kinetics of IMJ995 (area under the drug concentration-time curve - AUC)

    24 months

  • Number of participants with anti-CAR19 and/or anti-CAR22 antibodies

    24 months

  • Change from baseline in interferon (IFN)-gamma levels in peripheral blood mononuclear cells (PBMCs)

    24 months

  • +3 more secondary outcomes

Study Arms (1)

IMJ995 in ALL

EXPERIMENTAL

Dose escalation and expansion of IMJ995 single agent in ALL

Drug: IMJ995 single agent

Interventions

IMJ995 single agentDRUG

Single intravenous administration of IMJ995

IMJ995 in ALL

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients:
  • Evidence of CD19 and/or CD22 cell surface expression on B-ALL blasts in bone marrow or peripheral blood by flow cytometry at time of relapse or prior to study entry.
  • Pediatric, adolescent and young adult ALL patients:
  • years of age at the time of informed consent form (ICF) signature.
  • Relapsed or refractory CD19+ and/or CD22+ ALL after 3 or more lines of treatment OR after allogeneic HCT.
  • Must have received a CD19-directed CAR-T treatment (with or without blinatumomab), unless prior loss of CD19 cell surface expression occurred or have not been eligible for CD19 directed CAR-T treatment.
  • Lansky (age \< 16 years), Karnofsky (age 16-25 years) performance status ≥ 60%. ECOG (age \>25 years) performance status that is either 0 or 1 at screening.
  • Adult ALL patients aged ≥30 years:
  • ≥30 years of age at the time of informed consent form (ICF) signature.
  • Refractory or relapsed CD19+ and/or CD22+ ALL including at least one of the following:
  • After allogeneic HCT
  • After 2 or more lines of treatment, including blinatumomab and/or inotuzumab
  • Primary refractory disease (defined as failure to achieve a CR at the end of at least 1 induction chemotherapy)
  • First relapse occurring within 12 months from first remission
  • ECOG performance status that is either 0 or 1 at screening.

You may not qualify if:

  • Allogeneic HCT within 12 weeks prior to screening.
  • Presence of isolated extra-medullary disease, testicular involvement or bulky disease
  • Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome.
  • Patients with Burkitt's lymphoma/leukemia
  • History of active neurological auto immune or inflammatory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

December 23, 2021

Study Start

January 24, 2023

Primary Completion (Estimated)

August 13, 2026

Study Completion (Estimated)

August 13, 2026

Last Updated

December 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share