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Can antibody infusions outperform antibiotics in shielding CAR-T patients from infections?

NCT ID NCT07754682

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This phase III trial is testing whether regular antibody infusions (immunoglobulin replacement therapy) can prevent infections better than standard antibiotic prophylaxis in people who have received CAR-T cell therapy for B-cell acute lymphoblastic leukemia or B-cell lymphoma. CAR-T treatment can leave patients with low antibody levels, making them prone to infections. The study will compare the two preventive approaches over 12 months in 228 patients aged 16 to 80, measuring how many develop recurrent or severe infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Immunoglobulin replacement therapy (IgRT) compared with antibiotic prophylaxis
What this could lead to
If IgRT proves better than antibiotics, it could become the standard preventive care to reduce severe infections in patients after CAR-T therapy.
What could go wrong
The trial is still recruiting and results are not yet available. IgRT is costly and may not reduce infections more than antibiotics, which also carry risks like antibiotic resistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 228 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 16-80 years at inclusion 2. B-cell acute lymphoblastic leukemia or a B-cell lymphoma 3. With gamma globulins \<4g/L at the time of screening 4. Receiving CD19-targeted autologous CAR-T cells (with AMM in their indication) 5. Patients with childbearing potential\* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion. 6. Contraceptive measures for concerned patients 7. Informed consent signed by patient or legal representatives Exclusion Criteria: 1. Any medical history of intolerance to intravenous immunoglobulin 2. With renal failure calculated glomerular filtrate rate \<30 mL / min; 3. With hepatic failure or hepatitis or bilirubin\> 3 times the upper limit of normal, Serum ALT/AST \>=5N 4. With existing serious acute infection 5. Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial 6. No health insurance coverage 7. Females who are pregnant or breastfeeding 8. Participation in another interventional study or being

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia B-cell neoplasm Burkitt lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibiotic prophylaxis B-cell acute lymphoblastic leukemia (B-ALL) B-cell lymphoma Chimeric antigen receptor T-cell therapy Immunoglobulin therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.