Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMiltenyi Biomedicine GmbH

About this trial

The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up.

Patient has provided informed consent prior to enrollment.

Disqualifiers

No exclusion criteria

Trial design

Design model

Single group

Treatments tested in this trial

  • MB-CART19.1

    Biological/Vaccine

    Assessment of long-term safety and efficacy of MB-CART19.1 treatment.

  • MB-CART20.1

    Biological/Vaccine

    Assessment of long-term safety and efficacy of MB-CART20.1 treatment.

  • MB-CART2019.1

    Biological/Vaccine

    Assessment of long-term safety and efficacy of MB-CART2019.1 treatment.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Long-term follow-up of CAR T cell therapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse Events

Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies

Time frame
through study completion, up to 14 years

Secondary outcomes

1

Lymphocyte count

B and T lymphocyte count

Time frame
through study completion, up to 14 years
2

Height

Height

Time frame
through study completion, up to 14 years
3

Weight

Weight

Time frame
through study completion, up to 14 years
4

Tanner staging for pediatric patients

Tanner staging for pediatric patients

Time frame
through study completion, up to 14 years

Other outcomes

Sponsors and contacts

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